Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Lead Sponsor: Population Health Research Institute
|Source||Population Health Research Institute|
The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.
Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.
|Start Date||December 21, 2017|
|Completion Date||September 4, 2018|
|Primary Completion Date||September 4, 2018|
Intervention Type: Drug
Intervention Name: Tranexamic Acid
Description: 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.
Other Name: Cyklokapron
Inclusion Criteria: - Male or female >= 18 years old - Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy - Provide written informed consent Exclusion Criteria: - Poor (English) language comprehension - Minimally invasive valve surgery - Off-pump procedures - Emergency operations - Known history of increased bleeding disorder - Thromboembolic disease - Allergy to tranexamic acid - Severe renal impairment (eGFR <30 mL/min/1.73m2 )
- Male or female >= 18 years old
- Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
- Provide written informed consent
- Poor (English) language comprehension
- Minimally invasive valve surgery
- Off-pump procedures
- Emergency operations
- Known history of increased bleeding disorder
- Thromboembolic disease
- Allergy to tranexamic acid
- Severe renal impairment (eGFR <30 mL/min/1.73m2 )
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
|Has Expanded Access||No|
|Number Of Arms||2|
Label: TA Topical
Type: Active Comparator
Description: 1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.
Label: TA Intravenous
Type: Active Comparator
Description: 2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
|Study Design Info||
Intervention Model: Parallel Assignment
Intervention Model Description: Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The pharmacy will prepare 1 syringe of 50 ml of topical TA (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. TA 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.