Clinical trial

Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) Study

Name

DEPOSITION

Description

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

Trial arms

Trial start

2019-09-17

Estimated PCD

2023-11-28

Trial end

2023-11-28

Status

Terminated

Phase

Early phase I

Treatment

Tranexamic Acid

Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.

Arms:

Intravenous Tranexamic Acid/Placebo, Topical Tranexamic Acid/Placebo

Other names:

Cyklokapron

Size

3242

Primary endpoint

The proportion of patients experiencing an in-hospital seizure

Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

Eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The pharmacy will prepare 2 syringes of 50 ml of topical TxA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TxA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3242, 'type': 'ACTUAL'}}

Updated at

2023-12-08

1 organization

1 product

3 indications

Organization

Population Health Research Institute

Product

Indication

Indication

Indication