Clinical trials: Bleeding in Cardiac Surgery
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
Bleeding
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac…
- Trial name
- NCT01530399
- Testing
- MDCO 1, MDCO 2, MDCO 3
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 44 people
- Sponsor
- The Medicines Company
Heart Failure, Ventricular Dysfunction
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery.
- Trial name
- NCT01605019
- Testing
- CoSeal, BioGlue® Surgical Adhesive
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- The Methodist Hospital Research Institute
Hemorrhage, Soft Tissue Bleeding
EVARREST™ Fibrin Sealant Patch Post-Market Study
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and…
- Trial name
- EVARREST (NCT01902459)
- Testing
- EVARREST™ Fibrin Sealant Patch, Standard of Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
Cardiac Complication During Procedure
Prospective Double Blinded Randomized Control Study of the Use of Fibrinogen in High-Risk Cardiac Surgery
The aim of the study is to show that first line treatment with concentrated fibrinogen has superiority over the conventional therapy with fresh frozen plasma (FFP), platelets, and cryoprecipitate in perioperative management of…
- Trial name
- NCT01623531
- Testing
- Fibrinogen
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Nova Scotia Health Authority
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
Hemorrhage, Surgical, Hemorrhage Postoperative
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Trial name
- STAR-D (NCT05093504)
- Testing
- DrugSorb-ATR system
- Where
- 27 sites in United States
- Volunteers
- 9 people
- Sponsor
- CytoSorbents, Inc
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.
Valvular Heart Surgery
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest…
- Trial name
- NCT04244981
- Testing
- Prothrombin Complex Concentrate, Human, Fresh Frozen Plasma
- Where
- 2 sites in China
- Volunteers
- 476 people
- Sponsor
- SHI Jia
Bleeding, Surgical Blood Loss
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the…
- Trial name
- DEPOSITION (NCT03376061)
- Testing
- Tranexamic Acid
- Where
- Canada
- Volunteers
- 97 people
- Sponsor
- Population Health Research Institute
Coronary Artery Disease, Coronary Artery Bypass
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary…
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass, Erythrocyte Transfusion
- Trial name
- NCT00600704
- Testing
- Fluid Restriction Policy, Free fluid infusion
- Where
- Greece
- Volunteers
- 192 people
- Sponsor
- Larissa University Hospital
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Off Pump Coronary Artery Bypass Surgery
Tranexamic Acid in Off-pump Coronary Surgery
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in…
- Trial name
- TAOPCAB (NCT01064167)
- Testing
- Tranexamic Acid
- Where
- China
- Volunteers
- 231 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai 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, Surgical Blood Loss
DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.
- Conditions
- Bleeding, Surgical Blood Loss, Seizures
- Trial name
- DEPOSITION (NCT03954314)
- Testing
- Tranexamic Acid
- Where
- 16 sites in Canada, China and 4 more
- Volunteers
- 3,242 people
- Sponsor
- Population Health Research Institute
Congenital Heart Defect, Surgery-Induced Tissue Adhesions
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and…
- Conditions
- Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage
- Trial name
- NCT01330433
- Testing
- CoSeal Surgical Spray Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Loma Linda University
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Coronary Artery Disease
Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery
The goal of this project is to determine whether the use of tranexamic acid, a clot-promoting drug, applied topically over the heart in coronary artery bypass graft surgery (CABG) will reduce post operative blood loss.
- Trial name
- NCT01519245
- Testing
- Tranexamic Acid, normal saline
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Saskatchewan