Clinical trials: Bleeding in Cardiac Surgery
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
Hemostasis
Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.
- Trial name
- NCT01008436
- Testing
- Omni-stat Celox, Control
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Cardiochirurgia E.H.
Noonan Syndrome
Link Between Abnormal Bleeding and Coagulation Disorders in Noonan Syndromes
Noonan syndrome is a relatively rare genetic disorder, affecting around 1 in every 1,000 to 2,500 children born. Patients often have a tendency to bleed more easily, particularly from the skin or mucocutaneous tissue (such as…
- Trial name
- PlatNoon (NCT07259135)
- Testing
- Reuse of routine clinical and biological data
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Bordeaux
Cardiac Surgical Procedures, Blood Coagulation Disorders
Fibrinogen Concentrate In Children After Cardiac Surgery
The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac…
- Conditions
- Cardiac Surgical Procedures, Blood Coagulation Disorders, Fibrinogen, Cryoprecipitate
- Trial name
- FiCCS (NCT01187225)
- Testing
- Fibrinogen concentrate, Cryoprecipitate
- Where
- Brazil
- Volunteers
- 63 people
- Sponsor
- University of Sao Paulo
Bleeding, Cardiac Defect
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome.
- Conditions
- Bleeding, Cardiac Defect, Surgery--Complications, Fibrinogenopenia; Acquired
- Trial name
- ZEPLAST-PED (NCT04434001)
- Testing
- Fibrinogen Concentrate Human, Prothrombin Complex Concentrate, Fresh Frozen Plasma
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Policlinico S. Donato
Infant ALL, Congenital Heart Disease
Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery
In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery.
- Trial name
- NCT04454294
- Testing
- Control, Experimental Group (Absorption Group), Experimental Group (Milking Group)
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Acibadem University
Blood Loss, Congenital Heart Disease
Tranexamic Acid in Pediatric Cardiac Surgery
Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results.
- Trial name
- TXA (NCT00994994)
- Testing
- Tranexamic Acid
- Volunteers
- 160 people
- Sponsor
- Okayama University
Cardiac Surgery, Congenital Heart Disease
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery.
- Conditions
- Cardiac Surgery, Congenital Heart Disease, Cardiopulmonary Bypass, Fibrinogenemia
- Trial name
- NCT05525195
- Testing
- Congenital cardiac surgery
- Where
- Belgium
- Volunteers
- 932 people
- Sponsor
- Brugmann University Hospital
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
Pediatric HD, Bleeding
Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients
The aim of the current pilot study proposal is to compare the use of the purified human fibrinogen concentrate (Fibryga®, Octapharma USA) to cryoprecipitate for the treatment of cardiopulmonary bypass (CPB)-associated bleeding in…
- Trial name
- NCT04376762
- Testing
- Fibrinogen, Cryoprecipitate
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Virginia
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.
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
Bleeding
Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery
A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to…
- Trial name
- NCT02133378
- Testing
- Hemopatch, Traditional Hemostasis Techniques (dry or wet gauze compression or similar)
- Where
- Italy
- Volunteers
- 170 people
- Sponsor
- Cardiochirurgia E.H.
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
Blood Loss, Surgical, Pediatric Heart Surgery
Effects of Intraoperative Blood and Blood Product Consumption on Postoperative Results in Pediatric Cardiac Surgery
Blood products and intravenous fluids are frequently used in the treatment of children who have undergone cardiac surgery in order to maintain hemodynamic stability.
- Trial name
- NCT03291769
- Where
- Turkey (Türkiye)
- Volunteers
- 83 people
- Sponsor
- Cukurova University
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.
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.
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
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Bleeding
Tranexamic Acid (TXA) in Pediatric Cardiac Surgery
The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.
- Trial name
- Exacyl (NCT01141127)
- Testing
- Tranexamic Acid
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Centre Chirurgical Marie Lannelongue