Reducing bleeding episodes after open heart surgery, a clinical study of different routes of drug administration for Tranexamic acid.
- Conditions
- Health Condition 1: G40- Epilepsy and recurrent seizuresHealth Condition 2: I976- Postprocedural hemorrhage, hematoma and seroma of a circulatory system organ or structure following a procedure
- Registration Number
- CTRI/2023/03/050179
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.= 18 years of age
2.Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy.
3.Provide written informed consent
1.Allergy to tranexamic acid
2.Undergoing minimally invasive surgery
3.Fulfill any of the following transfusion risk factors (A-D):
A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active)
4.History of previous cardiac surgery
5.Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
6.Pre-operative hemoglobin > 170 g/L or <110 g/L
7.Pre-operative thrombocytopenia ( <50,000 platelets per µL)
8.Expected circulatory arrest
9.Pregnancy or breast feeding
10.Previously enrolled in the DEPOSITION trial
11.Refusal of blood products
12.Pericardiectomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients experiencing an in-hospital seizure.Timepoint: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
- Secondary Outcome Measures
Name Time Method The proportion of patients receiving in-hospital red blood cell transfusion.Timepoint: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)