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

Sponsors

Lead Sponsor: Population Health Research Institute

Source Population Health Research Institute
Brief Summary

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.

Detailed Description

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.

Overall Status Completed
Start Date December 21, 2017
Completion Date September 4, 2018
Primary Completion Date September 4, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Median Volume of Mediastinal Fluid Collected From Participants Fluid collected in the first 24 hours after the surgical procedure
Secondary Outcome
Measure Time Frame
Number of Participants With Seizures Patients will be followed post-operatively until hospital discharge
Number of Participants With Mortality Patients will be followed post-operatively until hospital discharge
Number of Participants With RBC Transfusion Intra-operative and post-operative RBC transfusions
Number of Participants With Re-operation for Bleeding or Tamponade Patients will be followed post-operatively until hospital discharge
Median Number of Hours Participants Spent in ICU Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
Mean Concentration of TxA in Plasma Collected From Participants on arrival in ICU within 3 hours
Enrollment 97
Condition
Intervention

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

Eligibility

Criteria:

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 )

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andre Lamy, MD MHSc Principal Investigator Population Health Research Institute
Location
Facility: Hamilton General Hospital
Location Countries

Canada

Verification Date

September 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

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.

Acronym DEPOSITION
Patient Data No
Study Design Info

Allocation: Randomized

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.

Source: ClinicalTrials.gov