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

January 26, 2021 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TA Topical
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.
Drug: 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.
Other Names:
  • Cyklokapron
Active Comparator: TA Intravenous
2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.
Drug: 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.
Other Names:
  • Cyklokapron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Volume of Mediastinal Fluid Collected From Participants
Time Frame: Fluid collected in the first 24 hours after the surgical procedure
Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure
Fluid collected in the first 24 hours after the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Seizures
Time Frame: Patients will be followed post-operatively until hospital discharge
Patients experiencing a post-operative seizure
Patients will be followed post-operatively until hospital discharge
Number of Participants With Mortality
Time Frame: Patients will be followed post-operatively until hospital discharge
The occurrence of death due to any cause
Patients will be followed post-operatively until hospital discharge
Number of Participants With RBC Transfusion
Time Frame: Intra-operative and post-operative RBC transfusions
Patients requiring a red blood cell transfusion
Intra-operative and post-operative RBC transfusions
Number of Participants With Re-operation for Bleeding or Tamponade
Time Frame: Patients will be followed post-operatively until hospital discharge
Occurrence of re-operation for the purpose of bleeding or cardiac tamponade
Patients will be followed post-operatively until hospital discharge
Median Number of Hours Participants Spent in ICU
Time Frame: Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
Number of hours participants spent in the intensive care unit (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
Time Frame: on arrival in ICU within 3 hours
Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU
on arrival in ICU within 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Andre Lamy, MD MHSc, Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Actual)

September 4, 2018

Study Completion (Actual)

September 4, 2018

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPOSITION 1.0 2017-07-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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