Coronary Artery Bypass Graft Surgery Clinical Trial
Official title:
The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.
Excessive bleeding during and after cardiac surgery is a serious complication. It exposes
patients to the risk of allogeneic blood transfusion or other blood products and the risk of
mediastinal re-exploration.Antifibrinolytic drugs like aprotinin and tranexamic acid are
proven to reduce bleeding tendency and transfusion requirement in cardiac surgery. The
efficacy of these drugs is proven, especially for the unspecific proteinase inhibitor
aprotinin, however, there are concerns about the safety and the high costs of this drug.
There are only limited head-to-head comparisons of these two drugs.
In this double-blind, prospective, controlled study the efficacy of aprotinin and tranexamic
acid is compared. Primary outcome is the 24 hours postoperative drainage blood loss and the
percentage of patients requiring allogeneic blood transfusion during the hospital stay.
Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for
combined and separate data analysis.The power of the study is calculated for this
subgroup-analysis.
Secondary outcome measurements are molecular marker of activation of hemostasis up to the
5th postoperative day.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00248885 -
Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)
|
N/A | |
Completed |
NCT04473287 -
The Effect of Reflexology After Coronary Artery Bypass Graft Surgery
|
N/A | |
Completed |
NCT03892460 -
Transitional Rehabilitation in CABG Patients
|
N/A | |
Completed |
NCT04238806 -
Desflurane,Brain Natriuretic Peptide and Cardiac Surgery
|
N/A | |
Terminated |
NCT01246011 -
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
|
Phase 4 | |
Completed |
NCT00402506 -
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
|
Phase 3 | |
Recruiting |
NCT03900026 -
Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery
|
Phase 4 | |
Completed |
NCT01095419 -
Effects of Massage Therapy on Sleep After Heart Surgery
|
N/A | |
Recruiting |
NCT05377983 -
The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft
|
N/A | |
Completed |
NCT03123107 -
Vitamin C in Cardiac Surgery Patients
|
Phase 1 | |
Terminated |
NCT00735722 -
A(f)MAZE-CABG Study
|
N/A | |
Recruiting |
NCT04652375 -
Outcomes After Albumin vs Lactated Ringer's Solution in CABG and AVR Procedures
|
N/A | |
Completed |
NCT05830682 -
Effect of Using Walking Aid on Mobility
|
N/A | |
Completed |
NCT05191745 -
Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery
|
Phase 3 | |
Enrolling by invitation |
NCT01127802 -
Changes of Functional Status, Symptoms Distress and Quality of Life in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
|
N/A | |
Completed |
NCT04111744 -
Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery
|
N/A | |
Active, not recruiting |
NCT01063491 -
Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study
|
Phase 3 | |
Completed |
NCT00618592 -
Does Pre-operative Carbohydrate Loading Reduce Insulin Resistance and Improve Outcomes in Elective Surgical Patients?
|
N/A | |
Withdrawn |
NCT04717817 -
Inspiratory Muscle Training Prior to Conventional and Minimal Invasive Heart Surgery
|
N/A | |
Withdrawn |
NCT00807521 -
Steroid-induced Reduction of Surgical Stress Study
|
N/A |