Clinical trials: Bleeding Cardiac Surgery Patients
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
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
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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
Coronary Artery Bypass Graft, Cardiopulmonary Bypass
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of…
- Trial name
- NCT01535222
- Testing
- MDCO-2010
- Volunteers
- 32 people
- Sponsor
- The Medicines Company
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first…
- Trial name
- NCT02239146
- Testing
- catridecacog
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
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
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.
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, 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.
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
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.
Postoperative Hemorrhage
Aprotinin US Special Access Protocol
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass…
- Trial name
- NCT00611845
- Testing
- Aprotinin (Trasylol, BAYA0128)
- Where
- 17 sites in United States
- Sponsor
- Bayer