title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Competing interests | The authors declare no competing interests. | PMC10122388 | ||
References | PMC10122388 | |||
Background | reperfusion injury | PRIMARY GRAFT DYSFUNCTION, HAND ISCHEMIA | Primary graft dysfunction (PGD) after lung transplantation (LuTx) contributes substantially to early postoperative morbidity. Both intraoperative transfusion of a large amount of blood products during the surgery and ischemia–reperfusion injury after allograft implantation play an important role in subsequent PGD devel... | PMC9996868 |
Methods | reduction of blood loss, coagulopathy | SECONDARY, COAGULOPATHY | We have previously reported a randomized clinical trial of 67 patients where point of care (POC) targeted coagulopathy management and intraoperative administration of 5% albumin led to significant reduction of blood loss and blood product consumption during the lung transplantation surgery. A secondary analysis of the ... | PMC9996868 |
Results | Compared to the patients in the control (non-POC) group, those in study (POC) group showed significantly superior graft function, represented by the Horowitz index (at 72 h after transplantation 402.87 vs 308.03 with | PMC9996868 | ||
Conclusions | coagulopathy | COAGULOPATHY | Utilization of a POC targeted coagulopathy management combined with Albumin 5% as primary resuscitative fluid may improve early lung allograft function, provide better circulatory stability during the early post-operative period, and have potential to decrease the incidence of PGD without negative effect on 1-year surv... | PMC9996868 |
Trial registration | This clinical trial was registered at ClinicalTrials.gov (NCT03598907). | PMC9996868 | ||
Keywords | PMC9996868 | |||
Background | pulmonary opacities, end-stage lung disease, blood loss, ARDS, hypoxemia, bleeding/coagulopathy, coagulopathy, normovolemia | LUNG, BLOOD LOSS, COMPLICATION, CHRONIC LUNG ALLOGRAFT DYSFUNCTION, SECONDARY, COAGULOPATHY, ARDS | Lung transplantation (LuTx) remains the ultimate treatment for end-stage lung disease refractory to optimized medical therapy. Post-implantation, long-term outcomes are impaired by ongoing medical factors including chronic lung allograft dysfunction (CLAD). CLAD (and its phenotypes) represents a major complication that... | PMC9996868 |
Methods | PMC9996868 | |||
Study design overview, surgical strategy and outcomes | blood loss, bleeding, coagulopathy, Coagulopathy | BLEEDING, LUNG, CLOT, COAGULOPATHY, BLOOD LOSS, LYSIS, SECONDARY, COAGULOPATHY, HEART | A secondary analysis of the Point of Care Management of Coagulopathy in Lung Transplantation trial (NCT03598907) was performed. This study was a single-site, prospective randomized controlled trial that examined the utilization of perioperative POC-targeted coagulopathy management in conjunction with 5% albumin solutio... | PMC9996868 |
Patient selection and enrollment | Coagulopathy | SECONDARY, LUNG, COAGULOPATHY | Patient selection and eligibility criteria for the current secondary analysis mirrored that of the Point of Care Management of Coagulopathy in Lung Transplantation trial and included patients who underwent LuTx at the University Hospital Motol between January 2018 and June 2020 [Randomization and detailed description o... | PMC9996868 |
PGD definition | HEART, LUNG | The definition of PGD was based on the latest International Society for Heart and Lung Transplantation (ISHLT) recommendation and was recorded 2 h after ICU admission (time 0) and then 24 h (time 24), 48 h (time 48) and 72 h (time 72) after LuTx [ | PMC9996868 | |
Statistical analysis | Statistical analyses were performed with R statistical software, version 3.4.4 (available online at The Horowitz index was calculated at each tracked time point (0, 24, 48, 72 h), and the measured values were evaluated with Welch’s two-sample t-test. The maximum level of norepinephrine (µg/kg/min) during the first 24 h... | PMC9996868 | ||
Results | PMC9996868 | |||
Study patients and study flow | blood loss | BLOOD LOSS | Patients were recruited during the period from January 2018 to June 2020, and based on the exclusion criteria, a total of 33/100 patients were excluded from the study. The non-POC group and POC group ultimately consisted of 36 and 31 patients, respectively. At this point, interim statistical analysis was performed, and... | PMC9996868 |
Primary graft dysfunction evaluation | Primary graft dysfunction, primary graft dysfunction | PRIMARY GRAFT DYSFUNCTION | The incidence of PGD development based on ISHLT criteria at each time point in the non-POC and POC groups is displayed in Table Primary graft dysfunction development in both groups in four tracked time periods. Data are presented as n (%)
Incidence of primary graft dysfunction after lung transplantation at 0, 24, 48 an... | PMC9996868 |
Horowitz index evaluation | Table Horowitz index and its differences between the non-POC and POC group at each tracked time. The Horowitz index is defined as arterial oxygen pressure (P
Horowitz index at each time point (0, 24, 48, 72 h) after lung transplant surgery. Values are presented as the mean and 95% CI. Abbreviations: HI: Horowitz index;... | PMC9996868 | ||
Norepinephrine dosage and albumin serum levels evaluation | The maximum single dose of norepinephrine (µg/kg/min) administered to every patient in both groups during the first 24 h was recorded. In the non-POC group and POC group, the maximum doses of norepinephrine were 0.379 and 0.193, respectively ( | PMC9996868 | ||
Postoperative mechanical ventilation duration and length of ICU stay and 1-year survival | Duration of mechanical ventilation and length of ICU stay after LuTx surgery were decreased in POC group. However, this difference did not cross the boundary for statistical significance as shown in Table Duration of mechanical ventilation and length of intensive care unit stay after LuTx surgery in non-POC vs POC grou... | PMC9996868 | ||
Discussion | bleeding, SIRS, intraoperative blood loss, blood loss, reperfusion injury, coagulopathy, Ischemia, TRALI | TRANSFUSION-RELATED ACUTE LUNG INJURY, BLEEDING, BLOOD LOSS, CYSTIC FIBROSIS, INTRAOPERATIVE BLOOD LOSS, COAGULOPATHY, ISCHEMIA | PGD negatively contributes to increased short-term and long-term morbidity and mortality after LuTx [Ischemia–reperfusion injury after lung allograft implantation has been shown to lead to PGD development [Transfusion of a large amount of blood products, especially FFP, to manage intraoperative blood loss during LuTx i... | PMC9996868 |
Conclusions | coagulopathy | COAGULOPATHY | The results of this study indicate that targeted coagulopathy management and 5% albumin solution solely used as volume replacement therapy during LuTx surgery may improve early lung allograft function, provide better circulatory stability during the early post-operative period, and have potential to decrease the incide... | PMC9996868 |
Acknowledgements | Tomas | The authors thank all the anesthesiologists and intensivists involved in this study, especially Jaroslav Hylmar, Stanislav Novotny, Michaela Sekerasova, Tereza Krskova, Milan Grund, Jana Polaskova, Silvie Binterova, Vladimir Bicek, Martin Malosek, Jiri Roith, Vojtech Simecek, Jan Sindelar, Jiri Bures, Zdenek Havelka an... | PMC9996868 | |
Authors’ contributions | JV and MD designed the study and collected the study data, JV, MD, JV Jr analyzed the data and wrote major part of the manuscript, JV, JV Jr, ZP, JB, TV, RL, AKM and MD participated in the performance of the research and/or substantially contributed to the writing of the manuscript. All authors edited the final manuscr... | PMC9996868 | ||
Funding | This study was supported by the Ministry of Health, Czech Republic – Conceptual Development of Research Organization, Motol University Hospital, Prague, Czech Republic (No. 64203 and No. 6028). This work was supported by the institutional project Cooperatio Program, research area SURG. These funding agencies played no ... | PMC9996868 | ||
Availability of data and materials | All data generated or analyzed in the current article are available from the corresponding author on reasonable request. | PMC9996868 | ||
Declarations | PMC9996868 | |||
Ethics approval and consent to participate | The study was approved by the ethical committee of University Hospital Motol with approval number EK-1402/17. Written informed consent was obtained from all included patients. The study was carried out in accordance with the declaration of Helsinki. | PMC9996868 | ||
Consent for publication | Not applicable. | PMC9996868 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9996868 | ||
References | PMC9996868 | |||
Background | AF, heart disease | HEART DISEASE | AF is a widespread heart disease affecting the well-being of patients and their family members physically and psychologically. Supporting patients and their family members could potentially facilitate regaining family strength and improve HRQoL. | PMC10019651 |
Methods | Anxiety, Depression, Atrial Fibrillation | HEART, ATRIAL FIBRILLATION | Patients with newly diagnosed AF were randomised to standard care or additional family-focused intervention with change in global score of the Atrial Fibrillation Quality of Life Questionnaire (AFEQT) as primary outcome after six months’ follow-up. Secondary outcomes included the Hospital Anxiety and Depression Score, ... | PMC10019651 |
Results | SECONDARY | Sixty-eight patients received standard care (n = 35) or family focused intervention (n = 33). The median change at the six-month follow-up on the global AFEQT score was 4.17 (-1.46–9.17) in the control group and 5.83 (-2.5–30) in the intervention group, yielding a median difference of -1.67 (p = 0.500). Change in ICE-F... | PMC10019651 | |
Conclusion | depression, anxiety | The family-focused intervention had a small positive but non-significant effect on HRQoL compared to standard care. To address the impact of AF on the patients and family members seems to improve anxiety and depression scores and perceived family support. | PMC10019651 | |
Data Availability | Data cannot be shared publicly because data contain potentially identifying or sensitive patient information. Agreggated data values are avaliable upon request from the first author. This is in accordance with "ethical and legal restrictions". It is in accordance with Danish legislation, here the Data Protection Act § ... | PMC10019651 | ||
Introduction | cardiac arrhythmia | ATRIAL FIBRILLATION (AF), CARDIAC ARRHYTHMIA | Atrial fibrillation (AF) is a widespread cardiac arrhythmia estimated to affect more than 20.9 million men and 12.6 million women worldwide [The European Society of Cardiology (ESC) guidelines recommend integrated AF care involving the family as a resource to ensure treatment compliance. Even so, the guidelines provide... | PMC10019651 |
Methods | PMC10019651 | |||
Trial design | The study was designed as a non-pharmacological, prospective, randomised trial with parallel groups in which patients were followed and assigned to either usual care or usual care plus a family-focused intervention. Intervention patients received a two-hour family group session and from one to three sessions of family-... | PMC10019651 | ||
Setting and data collection | RECRUITMENT | Patients from two Danish university hospital out-patient clinics in the Capital Region of Denmark were screened consecutively for eligibility. Nurses from the clinics recruited patients and their family members when having a consultation with the patient in the outpatient clinic. The recruitment period was highly affec... | PMC10019651 | |
Conventional treatment | arrhythmia | CONCOMITANT DISEASE, ARRHYTHMIA | The two recruiting outpatient clinics had similar standard care programs for AF patients. According to existing guidelines, the intervention group and the control group both received standard medical treatment for patients with AF [The standard care and treatment program comprised at least one cardiologist consultation... | PMC10019651 |
Family-focused intervention | The family-focused intervention was given in addition to the conventional treatment and care provided for patients with AF. The intervention was delivered based on the theoretical framework of family nursing, the Calgary Models and the Illness Belief Model [Patients and family members were offered the family-focused in... | PMC10019651 | ||
The themes for the two-hour family educational group sessions. | AF: atrial fibrillationEach family was invited to participate in up to one to three 60-minute FNTC sessions depending on their needs. The FNTCs were based on the Calgary Family Assessment Models (CFAM) and the Calgary Family Intervention Models (CFIM) in which the whole family is considered the unit of assessment and i... | PMC10019651 | ||
Contents of FNTCs based on: | PMC10019651 | |||
Adherence to the intervention | All FNTCs were digitally recorded, allowing the research team to evaluate if the family-focused intervention had been delivered as intended. In practice, this was done by the first author who revised 19 randomly selected recordings to establish if the components in | PMC10019651 | ||
Outcomes | Anxiety Depression, Atrial Fibrillation | HEART, ATRIAL FIBRILLATION | The patients completed a set of self-reported questionnaires, tapping answers directly into the data management program REDCap using an Ipad before receiving the intervention and at a six-month follow-up visit. The baseline and follow-up visits were conducted in the out-patient clinic and facilitated by the first autho... | PMC10019651 |
Measurements | depression, anxiety | CHRONIC ILLNESS | The AFEQT questionnaire is a self-administered disease-specific licensed and validated questionnaire sensitive to clinical changes in patients with AF [A high score, close to 100, indicates a high (good) HRQoL and a low score close to 0 a low HRQoL. Treatment satisfaction is not calculated in the overall global AFEQT s... | PMC10019651 |
Sample size | A sample size of 50 patients in two arms (a total of 100 patients) was deemed sufficient for detection of an 11-point difference on the AFEQT with an expected standard deviation of 20, a power of 80% and a significance level of 0.05. Calculation was based on a two-sided independent two-sample t-test. When measuring HRQ... | PMC10019651 | ||
Statistical analysis | Continuous variables are presented as mean with standard deviation (SD) or median with interquartile range (IQR) depending on distribution of the variable. Categorical variables are presented as counts and percentiles. The within group change was calculated as follow-up minus baseline and presented as median. The chang... | PMC10019651 | ||
Ethical considerations | All patients and family members received written and oral information about the trial and gave written consent before participating [ | PMC10019651 | ||
Results | The original plan was to recruit ten patients with a family member per month during a 12-month period from November 2019 (first patient recruited 28 | PMC10019651 | ||
Consolidated standards of reporting trials (Consort) flowchart. | The mean age of the patients was 68 years in both groups. The intervention group (n = 33) counted 22 male patients and 11 female patients; the control group (n = 35), 22 male patients and 13 female patients. Patients’ AF symptoms varied considerably; from almost no symptoms to symptoms disabling their everyday life. Tw... | PMC10019651 | ||
Baseline characteristics of randomised patients. | ATRIAL FIBRILLATION | *Baseline data are self-reported **Other antiarrhythmic drugs, e.g,. amiodarone.*AF: atrial fibrillation. BMI = Body Mass Index. *NOAC = Novel oral anticoagulation.All categorical variables are presented as frequencies with percentages.All continuous variables are presented as median with interquartile range. | PMC10019651 | |
Patient adherence to two- educational group session and number of FNTC´s. | *FNTC: family nursing therapeutic conversation*Adherence was calculated as how many elements each patient attended during the intervention period | PMC10019651 | ||
Intervention effect on the primary outcome and secondary outcomes | At baseline, a difference was observed between the groups’ self-reported HRQoL measured on the global AFEQT score with a median score of 76.67 (61.67–80.83) in the control group versus 63.75 (47.50–78.54) in the intervention group. The median change at the six-month follow-up on the Global AFEQT score was 4.17 (-1.46–9... | PMC10019651 | ||
Primary outcomes on AFEQT. | atrial fibrillation, depression, anxiety | ATRIAL FIBRILLATION | All estimates except change difference are presented as median with interquartile range, change difference presented as difference in median change with 95% confidence interval. AFEQT: atrial fibrillation Quality of life.*p values are based on Wilcoxon sum-rank test comparing control and intervention changeOutcomes on ... | PMC10019651 |
Secondary outcomes on the HADS, EHRA, ICE-EFFQ and ICE-FPSQ. | Depression, Anxiety | HEART, SENSITIVITY | All estimates except change difference are presented as median with interquartile range, change difference presented as difference in median change with 95% confidence interval.HADS: Hospital Anxiety and Depression Scale. EHRA score: European Heart Rhythm Association score. ICE-EFFQ: Ice Expressive Family Functioning. ... | PMC10019651 |
Discussion | depression, heart failure, insecurity, anxiety | HEART FAILURE, SECONDARY | No statistically significant improvement from the intervention was found for the six months change on Global AFEQT score, compared to standard care. Additionally, confidence intervals for the estimates were wide, giving a large uncertainty and making interpretation about the size of the difference hard. Adjustments for... | PMC10019651 |
Strengths and limitations | SECONDARY, BLIND | The methodology of the study using an intervention group vs. a control group in a RCT design is a strength in order to avoid systematic errors and the intervention and the control group were not clinically different from each other in the descriptive baseline characteristics, possible differences were present for outco... | PMC10019651 | |
Conclusion | Family-focused intervention did not show an improvement on the global AFEQT score compared to traditional treatment. However, given the large uncertainty of the estimates it is possible that relevant effects could be present, because of this no conclusive answer about this association can be made based on this study. | PMC10019651 | ||
Supporting information | PMC10019651 | |||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | RECRUITMENT | (DOC)Click here for additional data file.(DOCX)Click here for additional data file.(PDF)Click here for additional data file.The authors take this opportunity to express their gratitude to all patients and family members, to project nurses Marianne Nygaard Pedersen and Jennie Schier who delivered the family-focused inte... | PMC10019651 | |
References | PMC10019651 | |||
Background | This trial aimed to evaluate the anti-obesity effects and safety of Neoagaro-oligosaccharides (NAOs) in humans in a 16 week, randomized, double-blind, placebo-controlled clinical trial. | PMC10585797 | ||
Methods | overweight or obese | One hundred overweight or obese subjects with a body mass index of 23 to 34.9 kg/m | PMC10585797 | |
Results | After 16 weeks of intervention, the group administered with NAOs had statistically significant decreases in visceral fat area and visceral-subcutaneous fat area ratio compared to the placebo group. The NAOs group suppressed the increase in weight and BMI compared to the placebo group, which was significant between grou... | PMC10585797 | ||
Conclusions | obesity | OBESITY | These results suggest that NAOs have a beneficial effect on obesity. Thus, NAOs could be used as an anti-obesity supplement without side effects. | PMC10585797 |
Trial registration | cris.nih.go.kr: (KCT0006640, 07/10/2021). | PMC10585797 | ||
Keywords | PMC10585797 | |||
Methods | PMC10585797 | |||
Study design | MAY | This 16-week, single-center, randomized, double-blind, placebo-controlled, parallel-group, clinical study was conducted at Wonkwang University Korean Medicine Hospital in Jeonju from August 2021 to May 2022. The study protocol and informed consent form were approved by the Institutional Review Board (IRB) of Wonkwang U... | PMC10585797 | |
Study subjects | obesity, hypersensitivity, diabetic, medicine abuse | OBESITY, HYPERSENSITIVITY, GASTROINTESTINAL DISEASE | One hundred participants were eligible after screening tests such as questionnaires, physical examinations, and laboratory examinations. They were enrolled within two weeks after providing informed consent and before they were given supplement.Inclusion criteria were as follows: (1) those aged between 19 and 65 years o... | PMC10585797 |
Study products | Test products used in this study were provided by Dyne Bio Inc.(Sungnam, Korea). As described in previous studies [
Representative chromatograms of NAOs based on high-performance liquid chromatography (HPLC) analysis of Neoagarotetraose (DP4) and Neoagarohexaose (DP6)The 3 g/day dose is based on our preclinical studies... | PMC10585797 | ||
Efficacy outcome measurements | All subjects were subjected to efficacy evaluation before and after intake for 16 weeks during the study period. To measure abdominal fat area, subjects underwent a computed tomography (CT; WCT-200-140, Hispeed Dual) scan. Ab-dominal fat CT scans were taken with subjects lying on their backs. Total abdominal fat area (... | PMC10585797 | ||
Safety Outcome measurements | ADVERSE EVENTS, BLOOD | To evaluate safety, all adverse events (AEs) were monitored. Laboratory tests, urinalysis, vital signs, and electrocardiograms were performed before and after 16 weeks of administration. Laboratory tests included hematological tests [white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit, platelets] and b... | PMC10585797 | |
Dietary intake and physical activity assessment | During the study period, subjects maintained their usual dietary intake. Changes in dietary intake were evaluated through a standardized 3-day dietary record (2 days on weekdays, 1 day on weekends). Dietary intake was analyzed by a trained dietitian. Total daily intakes of energy, carbohydrates, lipids, protein, and fi... | PMC10585797 | ||
Statistical analysis | The sample size was referenced from a similar previous study [All statistical analyses were performed using SAS® (version 9.4; SAS Institute, Cary, NC, USA). Continuous variables were presented as means ± standard deviation (SD) and categorical variables were presented as frequencies. Data analysis for efficacy was per... | PMC10585797 | ||
Results | PMC10585797 | |||
Discussion | Obesity, obesity, stroke, CVD, overweight, weight loss | OBESITY, ADVERSE REACTIONS, OBESITY, OBESE, CVD, STROKE, CHRONIC DISEASES, BLIND, TYPE 2 DIABETES | We performed a 16-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the anti-obesity efficacy and safety of NAOs in overweight and obese subjects. After 16 weeks of intake, VFA and VSR were significantly reduced in the NAOs group, and weight and BMI were significantly suppressed from increas... | PMC10585797 |
Acknowledgements | We would like to express our gratitude to all study subjects and researchers. | PMC10585797 | ||
Author contributions | Conceptualization and study design: HIB, KCH, YKP, JHL, EJK, HJK, and JCJ; Investigation: JCJ; Statistical analysis: YKP; Data interpretation: HIB, KCH, YKP, and JCJ; Manuscript preparation: HIB, KCH, YKP, and JCJ; Fund collection: JHL, EJK, and HJK. All authors have read and approved the final manuscript. | PMC10585797 | ||
Funding | This research was supported by Korea Institute of Marine Science & Technology Promotion(KIMST) funded by the Ministry of Oceans and Fisheries, Korea (20200034). | PMC10585797 | ||
Data availability | The datasets generated and/or analyzed during the study are not publicly available to study subject confidentiality but are available from the corresponding author on reasonable request. | PMC10585797 | ||
Declarations | PMC10585797 | |||
Ethics approval and consent to participate | This research included clinical trial and authors have included a statement that informed consent was obtained for experimentation with subject. All the procedures for the clinical trial were approved by the Institutional Review Board of Wonkwang University Korean Medicine Hospital (IRB approval No.: WUJKMH-IRB-2021-00... | PMC10585797 | ||
Consent for publication | Not applicable. | PMC10585797 | ||
Competing interests | The authors declare no competing interests. | PMC10585797 | ||
Abbreviations | diabetes | DIABETES | adverse eventsalanine transaminaseaspartate transaminasebody fat massbody mass indexblood urea nitrogencomputer-Aided Nutritional analysis programcreatine kinasecardiovascular diseaseclinical Research Information Servicecomputed tomographydiastolic blood pressuredual-energy X-ray absorptiometrygamma-glutamyl transferas... | PMC10585797 |
References | PMC10585797 | |||
Abstract | These authors are co‐first authors. | PMC10646994 | ||
Objective | intracranial atherosclerotic stroke | This study aimed to investigate whether treatment with adjunct intravenous tirofiban is associated with improved outcomes following successful reperfusion in patients with intracranial atherosclerotic stroke. | PMC10646994 | |
Methods | artery atherosclerotic, sICH, stroke, Vessel Occlusion Stroke, Cerebral Ischemia | INTRACRANIAL HEMORRHAGE, STROKE, CEREBRAL ISCHEMIA | Patients with intracranial large artery atherosclerotic (LAA) stroke and an expanded Treatment in Cerebral Ischemia angiographic score of 2b50 to 3 from the Effect of Intravenous Tirofiban versus Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke (RESCUE BT) trial were incl... | PMC10646994 |
Results | intracranial LAA stroke | Among the 382 patients with intracranial LAA stroke and successful reperfusion, 175 patients (45.8%) were treated with intravenous tirofiban and 207 (54.2%) with placebo. The proportion of patients with independent functional outcome at 90 days was 54.3% (95 out of 175) with tirofiban and 44.0% (91 out of 207) with pla... | PMC10646994 | |
Interpretation | sICH, intracranial LAA stroke | Among patients with acute intracranial LAA stroke and successful reperfusion following endovascular thrombectomy, adjunct intravenous tirofiban was associated with a higher rate of independent functional outcome, without higher rates of sICH or mortality. Confirmatory randomized trials in these patients are desirable. | PMC10646994 | |
Introduction | artery atherosclerotic, stroke, vessel occlusion, microcirculatory obstructions, acute ischemic stroke | STROKE, HYPOPERFUSION, ARTERY OCCLUSION | Endovascular thrombectomy (EVT) is the standard treatment to improve functional outcomes in acute ischemic stroke patients with large vessel occlusion.Among patients with successful reperfusion with EVT, residual blood flow impairment is of two types: macrocirculatory—angiographically visible occlusions in more distal ... | PMC10646994 |
Methods | PMC10646994 | |||
Study participants | artery atherosclerosis | ISCHEMIC STROKE | The RESCUE BT trial was a multicenter, randomized, double blinded clinical trial conducted at 55 hospitals in China from October 2018 to October 2021. Details of trial design and topline results have been described previously.For the current post hoc study, additional inclusion criteria were, (6) diagnosis of intracran... | PMC10646994 |
Study treatments and interventions | The study drug was administered intravenously within 5 min after randomization. Eligible participants in the tirofiban group received intravenous bolus followed by continuous infusion of tirofiban (10 μg/kg bolus and then 0.15 μg/kg/min maintenance for up to 24 h), participants in the placebo group received saline. A r... | PMC10646994 | ||
Outcomes measures | Bleeding, sICH | BLEEDING, SECONDARY, INTRACEREBRAL HEMORRHAGE | This analysis used the same primary and all applicable secondary efficacy analyses used for the parent trial. The primary efficacy outcome measure was the proportion of patients functionally independent (modified Rankin Scale [mRS] score of 0 to 2) at 90 days. The mRS score is an ordered scale ranging from 0 (no sympto... | PMC10646994 |
Statistical analysis | REGRESSION, SECONDARY | Continuous variables were reported as medians (interquartile ranges) and categorical variables as numbers (percentages). Baseline characteristics between patients with and without intravenous tirofiban were compared by using the Wilcoxon rank sum test or chi‐squared test as appropriate. The main efficacy outcome was es... | PMC10646994 |
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