Clinical trials: Bleeding Cardiac Surgery Patients
Cardiac Surgery, Cardiopulmonary Bypass
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding
- Trial name
- APACHE (NCT04804345)
- Testing
- standard of care
- Where
- 7 sites in France
- Volunteers
- 693 people
- Sponsor
- University Hospital, Bordeaux
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Hemorrhage, Surgical, Blood Loss, Surgical
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent…
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Trial name
- STAR-T (NCT04976530)
- Testing
- DrugSorb-ATR system
- Where
- 29 sites in United States, Canada
- Volunteers
- 140 people
- Sponsor
- CytoSorbents, Inc
Deficiency; Fibrinogen, Acquired
FIBrinogen REplenishment in Surgery
This is a pragmatic, prospective, multi-center, randomized, active-control, single-blinded, non-inferiority phase 3 trial in adult cardiac surgical patients.
- Trial name
- FIBRES (NCT03037424)
- Testing
- Octafibrin, Cryoprecipitate
- Where
- 11 sites in Canada
- Volunteers
- 827 people
- Sponsor
- University Health Network, Toronto
Analgesia, Functional Endoscopic Sinus Surgery
ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
During functional endoscopic sinus surgery(FESS), low-pressure anesthesia is often applied, aiming to decreased operative blood loss, and anesthetics, narcotics and antihypertensive agents are given to achieve desirable low blood…
- Conditions
- Analgesia, Functional Endoscopic Sinus Surgery, Heart Rate Variability, Opioid Consumption
- Trial name
- NCT04319913
- Testing
- analgesia nociception index
- Where
- Taiwan
- Volunteers
- 120 people
- Sponsor
- Mackay Memorial Hospital
Bleeding, Hemorrhage
Protamine in Cardiac Surgery and Haemostasis
Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has…
- Trial name
- PROTT (NCT01608971)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Bleeding in Cardiac Surgery
Factor Replacement in Surgery
This is a multicentre, randomized, active-control, pragmatic, Phase 2 pilot study in adult cardiac surgery patients. Two Canadian hospitals will participate, and it is estimated that the study will take approximately 9 months to…
- Trial name
- FARES (NCT04114643)
- Testing
- Prothrombin Complex Concentrate, Frozen Plasma
- Where
- Canada
- Volunteers
- 103 people
- Sponsor
- University Health Network, Toronto
Cardiac Surgical Procedures, Blood Transfusion
Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.
- Conditions
- Cardiac Surgical Procedures, Blood Transfusion, Tranexamic Acid
- Trial name
- NCT04911413
- Testing
- Tranexamic acid
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of…
- Conditions
- Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion, Aortic Valve Replacement, Coronary Artery Bypass Graft Surgery
- Trial name
- NCT00396760
- Testing
- aprotinin or tranexamic acid
- Where
- Germany
- Volunteers
- 220 people
- Sponsor
- German Heart Center
Hemorrhage
Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.
In this study we will investigate whether tranexamic acid given as an intravenous bolus injection before start of surgery, followed by a continuous infusion during surgery reduces, perioperative hemostatic activation, and…
- Trial name
- NCT00375466
- Testing
- Tranexamic acid
- Where
- Norway
- Volunteers
- 63 people
- Sponsor
- St. Olavs Hospital
Coronary Artery Disease, Valvular Heart Disease
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Congenital Heart Disease in Adolescence, Post Operative Wound Infection
- Trial name
- NCT05229276
- Testing
- Sternum Guard, Bone Wax
- Where
- Indonesia
- Volunteers
- 414 people
- Sponsor
- Universitas Indonesia
Bleeding, Platelets
Autologous Cold-stored Apheresis Platelets
The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design.
- Conditions
- Bleeding, Platelets, Cardiopulmonary Bypass, Cardiac Surgery
- Trial name
- Auto-PLTS (NCT07064954)
- Testing
- Autologous Cold-Stored Platelets, Allogeneic Room Temperature-Stored Platelets (Standard of Care)
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- University Health Network, Toronto
Surgical Procedure, Non-cardiac, Cardiovascular Disease Patients
Perioperative Ischemia Versus Perioperative Bleeding During Non-cardiac Surgery in Cardiac Patients
The aim of the study is to analyze the present use of antithrombotic therapy on a large cohort of consecutive cardiacs undergoing non-cardiac surgery.
- Conditions
- Surgical Procedure, Non-cardiac, Cardiovascular Disease Patients, Perioperative Period
- Trial name
- PRAGUE-14 (NCT01897220)
- Where
- 2 sites in Czechia
- Volunteers
- 1,200 people
- Sponsor
- Charles University, Czech Republic
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
- Trial name
- NCT00914589
- Testing
- catridecacog
- Where
- 32 sites in United States, Canada and 8 more
- Volunteers
- 479 people
- Sponsor
- Novo Nordisk A/S
Cerebral Hemorrhage, Head Injury
Biomarkers Correlation With Volemia
The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7…
- Conditions
- Cerebral Hemorrhage, Head Injury, Non Traumatic Post Surgery, Poly Trauma Patients Without Heart Failure
- Trial name
- ENVOL (NCT01858675)
- Testing
- Biomarkers, red blood cells and plasma assessment
- Where
- France
- Volunteers
- 66 people
- Sponsor
- ThermoFisher Scientific Brahms Biomarkers France
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Patients Undergoing Elective Coronary Artery Bypass Graft
Lansoprazole Preventing Gastroduodenal Stress Ulcerations
The primary objective of this study is to determine whether lansoprazole, administered intravenously, can protect patients undergoing cardiac surgery from the development of and/or progression of previously undetected acid/peptic…
- Trial name
- NCT00220909
- Testing
- Lansoprazole
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Temple University
Surgery, Platelet Dysfunction
Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery
This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.
- Trial name
- NCT03049566
- Testing
- preoperative questionnaires
- Where
- Germany
- Volunteers
- 805 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Bloodloss
This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery
The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery.
- Trial name
- NCT00801190
- Testing
- HES (130/0.4), Ringer's Lactate
- Volunteers
- 500 people
- Sponsor
- St. Boniface Hospital
Hypovolemia, Hemorrhage
Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac…
- Conditions
- Hypovolemia, Hemorrhage, Fluid Responsiveness
- Trial name
- MOSTCARE-PED (NCT04186416)
- Testing
- Mostcare® device, Transthoracic cardiac ultrasound
- Where
- France
- Volunteers
- 19 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris