Clinical trials: Bleeding Cardiac Surgery Patients
Acute Coronary Syndrome
Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor
Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS.
- Trial name
- RAPID CABG (NCT02668562)
- Testing
- Early CABG (Day 2-3 after ticagrelor discontinuation), Delayed CABG (Day 5-7 after ticagrelor discontinuation)
- Where
- 2 sites in Canada
- Volunteers
- 143 people
- Sponsor
- Ottawa Heart Institute Research Corporation
Blood Loss, Surgical
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
- Trial name
- HAVAS (NCT00618293)
- Testing
- Haemate HS, NaCl-solution
- Where
- Germany
- Sponsor
- Heinrich-Heine University, Duesseldorf
Genetic Polymorphism
The Role of Platelet Surface α2β1 Integrin Expression as a Risk Factor in Thrombotic and/or Bleeding Complications
This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite.
- Trial name
- NCT00603148
- Where
- United States
- Volunteers
- 475 people
- Sponsor
- Vanderbilt University
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
Anemia, Blood Loss Anemia
Patient Blood Management In CARdiac sUrgical patientS
Nowadays up to 40% of patients undergoing cardiac surgery receives at least 1 unit of red blood cell transfusion during surgery or during the first week after surgery.
- Conditions
- Anemia, Blood Loss Anemia, Iron-deficiency, Iron Deficiency Anemia
- Trial name
- ICARUS (NCT04744181)
- Testing
- Ferric carboxymaltose, B vitamin, Folic acid
- Where
- Italy
- Volunteers
- 479 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Critically Ill Patients, Cardiac Surgery
Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition.
- Conditions
- Critically Ill Patients, Cardiac Surgery, Trauma, Subarachnoid Hemorrhage
- Trial name
- Etude-AOX (NCT00515736)
- Testing
- Selenium (Se), Zinc (Zn), Vitamin C, Vitamin B1, Vitamin E
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Fibrinogen Deficiency in Complex Cardiac Surgery
Haemocomplettan® P During Elective Complex Cardiac Surgery
Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.
- Trial name
- NCT01124981
- Testing
- Haemocomplettan® P
- Where
- 2 sites in Netherlands
- Volunteers
- 120 people
- Sponsor
- Isala
Coagulopathy, Rethoracotomy
Modified Ultrafiltration in Cardiac Surgery
The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.
- Conditions
- Coagulopathy, Rethoracotomy, Blood Loss, Transfusion Requirements
- Trial name
- NCT00998647
- Testing
- modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Goethe University
Hemorrhage
Indomethacin and Cardiac Bypass Surgery
Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and…
- Trial name
- NCT01073670
- Testing
- Indomethacin, Acetaminophen & Indomethacin, Acetaminophen
- Where
- Canada
- Volunteers
- 82 people
- Sponsor
- Queen's University
Anticoagulation Treatment Overdose, Heart Valve Diseases
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
Until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve.
- Trial name
- SYSU-WARFA (NCT01633957)
- Testing
- Genotype-based Warfarin Initiation model, clinical factor-based warfarin initiation model
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Xi Zhang
Perioperative Bleeding
Platelet Function Testing Help and Intraoperative Bleeding Risk for Patients Who Are on Plavix Prior to Surgery
A large number of patients are currently on Antiplatelet inhibition using aspirin or Plavix therapy (A Thieno pyridine - ADP mediated platelet inhibitor).
- Trial name
- NCT00653900
- Where
- United States
- Sponsor
- Cedars-Sinai Medical Center
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
Postoperative Bleeding
Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.
- Trial name
- BIANCA (NCT01606865)
- Where
- Austria
- Volunteers
- 207 people
- Sponsor
- Medical University of Graz
Atrial Fibrillation, Anticoagulant-induced Bleeding
Perioperative Management of Factor Xa Inhibitors
This study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor Xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at…
- Trial name
- PERIXa (NCT05801068)
- Testing
- Factor Xa Inhibitor
- Where
- South Korea
- Volunteers
- 2,500 people
- Sponsor
- Seoul National University Hospital
Venous Thromboembolism, Atrial Fibrillation
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the…
- Trial name
- GIHP-NACO (NCT02185027)
- Testing
- complications and compliance with GIHP recommendations
- Where
- 41 sites in Belgium, France
- Volunteers
- 1,166 people
- Sponsor
- University Hospital, Grenoble
Chest Tube Output, Allogeneic Blood Transfusions
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output.
- Trial name
- HEART-PoC (NCT01402739)
- Testing
- Point of Care Coagulation Monitoring Guided Transfusion Algorithm, standard coagulation monitoring guided transfusion algorithm
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Michael Sander
Bleeding
Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.
- Trial name
- NCT00778492
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Sheba Medical Center
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
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.
Central Venous Catheterization
Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance
Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein.
- Trial name
- NCT04962945
- Testing
- Oblique-axis approach group, Long-axis approach group
- Where
- China
- Volunteers
- 194 people
- Sponsor
- Guowei Tu