Clinical trials: Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass
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
Coagulopathy, Congenital Heart Disease
FFP Usage in Pediatric CV Surgery
When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg.
- Trial name
- NCT05819788
- Where
- Canada
- Volunteers
- 431 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Congenital Heart Disease
Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery
The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital…
- Trial name
- NCT04807621
- Testing
- Platelet transfusion, Fibrinogen concentrate
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Sahlgrenska University Hospital
Blood Coagulation Disorder, Postoperative Blood Loss
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion.
- Conditions
- Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event, Fibrinolysis; Hemorrhage
- Trial name
- NCT07164300
- Testing
- Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h, Tranexamic acid at a dose of 20 mg/kg, Tranexamic acid at a dose of 30 mg/kg
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- University of Ioannina
Perioperative Bleeding, Coagulopathy During Cardiac Surgery
Flow-Based Platelet Function Assessment Using Total Thrombus-Formation Analysis System (T-TAS) and Early Bleeding After Cardiac Surgery With Cardiopulmonary Bypass (CPB)
The goal of this observational study is to learn how flow-based platelet function measured with the Total Thrombus-formation Analysis System (T-TAS) relates to early postoperative bleeding in adults undergoing cardiac surgery…
- Conditions
- Perioperative Bleeding, Coagulopathy During Cardiac Surgery, Platelet Dysfunction, Cardiac Surgery
- Trial name
- TTAS-CPB (NCT07619261)
- Testing
- Total Thrombus-formation Analysis System (T-TAS)
- Volunteers
- 30 people
- Sponsor
- Hospital de la Santa creu i Sant Pau - Barcelona
Cardiac Surgical Procedures, Cardiopulmonary Bypass
Sequestration of Platelets Prior to Bypass Reduces Bleeding After Cardiac Surgery
Excessive bleeding is common after cardiac surgery. This may result in patients receiving a blood transfusion or suffering the life-threatening complication of cardiac tamponade.
- Conditions
- Cardiac Surgical Procedures, Cardiopulmonary Bypass, Blood Platelet Disorders, Blood Coagulation Disorders
- Trial name
- NCT00359398
- Testing
- Platelet rich plasma sequestration
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass
Coagulopathy in Cardiac Surgery
Coagulopathy in cardiac surgery; a quaternary-care academic center experience Objectives: Primary: To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop…
- Trial name
- NCT03475940
- Where
- 2 sites in Thailand
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers
This trial is conducted in Japan. The aim of this trial is to investigate the safety profile of recombinant factor XIII (rFXIII) assessed by the occurrence of adverse events in healthy Japanese subjects.
- Conditions
- Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass, Healthy
- Trial name
- NCT01153997
- Testing
- catridecacog
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Coagulopathy, Cardiopulmonary Bypass
Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy
This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global…
- Conditions
- Coagulopathy, Cardiopulmonary Bypass, Cardiac Surgery
- Trial name
- PREDIPOC (NCT06230640)
- Testing
- In vitro medical diagnostic device TEG6s® Platelet Mapping
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Montpellier
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
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
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 Antithrombin Deficiency
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating…
- Trial name
- NCT06096116
- Testing
- Human plasma derived antithrombin
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 120 people
- Sponsor
- Octapharma
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
Platelet Function Tests, Thrombin Generation Tests
Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis.
- Conditions
- Platelet Function Tests, Thrombin Generation Tests, Perioperative Coagulopathy
- Trial name
- NCT02833025
- Testing
- Thrombin generation and Platelet Function Testing
- Where
- Canada
- Volunteers
- 130 people
- Sponsor
- The Hospital for Sick Children
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
C.Surgical Procedure; Cardiac, Blood Transfusion
Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions. Treatment of such complication often necessitates various combinations therapeutic intervention including…
- Conditions
- C.Surgical Procedure; Cardiac, Blood Transfusion, Blood Coagulation Disorders, Bypass, Cardiopulmonary
- Trial name
- IMOTEC (NCT02972684)
- Testing
- Thrombo-elastometry POC testing
- Where
- 15 sites in France
- Volunteers
- 1,098 people
- Sponsor
- Nantes University Hospital
C.Surgical Procedure; Cardiac, Blood Coagulation Disorders
Fibrinogen Concentrate In Children Cardiac Surgery 2
The purporse of this study is evaluate whether fibrinogen concentrate reduces postoperative bleeding in pediatric cardiac surgery with cardiopulmonary by-pass.
- Conditions
- C.Surgical Procedure; Cardiac, Blood Coagulation Disorders, Hypofibrinogenemia
- Trial name
- FiCCS2 (NCT03884725)
- Testing
- Fibrinogen Concentrate, control
- Where
- Brazil
- Volunteers
- 42 people
- Sponsor
- Filomena R B G Galas