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

December 1, 2023 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Terminated

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 (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA 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)

3242

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Ingrid Copland, CCRA
  • Phone Number: 40368 905-527-4322
  • Email: cogency@phri.ca

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences - General Hospital
      • Montreal, Ontario, Canada
        • CHUM
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada
        • CIUSSS NIM/Hôpital Sacré-Coeur de Montréal
      • Quebec City, Quebec, Canada
        • IUCPQ
  • China
      • Beijing, China
        • Beijing Anzhen Hospital
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Czechia
      • Třinec, Czechia
        • Nemocnice Agel Třinec
  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • Petrovsky National Research Centre
      • Novosibirsk, Russian Federation
        • E.Meshalkin National Medical Research Center
      • Saint-Petersburg, Russian Federation
        • Saint-Petersburg State University 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

Description

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

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: Topical Tranexamic Acid/Placebo
Topical Tranexamic Acid 5g to 10g (50 to 100mL) or placebo. The topical will be poured into the pericardial and mediastinal cavities after protamine administration.
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: Intravenous Tranexamic Acid/Placebo
Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.
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
The proportion of patients experiencing an in-hospital seizure
Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid administration for reducing the risk of in-hospital seizure.
Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients in-hospital who receive red blood cell transfusions
Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) compared with intravenous tranexamic acid administration is associated with a non-inferior risk of in-hospital red blood cell transfusion.
Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood product transfusions
Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
Analyzed using an ANCOVA model. In such a model, bags of blood product will be included as a dependent variable, whereas dose of tranexamic acid and treatment will be included as covariates.
Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
Re-operation for bleeding or tamponade
Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
Analyzed with a binomial regression
Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
Duration of ICU stay
Time Frame: Number of hours in ICU are being collected at the Post-Operative Visit. Hour collection will start upon arrival at ICU post surgery and stop at ICU exit, up to 10 days maximum.
Analyzed using an ANCOVA model.
Number of hours in ICU are being collected at the Post-Operative Visit. Hour collection will start upon arrival at ICU post surgery and stop at ICU exit, up to 10 days maximum.
MACE (Death, non-fatal Myocardial Infarction (MI), or non-fatal stroke)
Time Frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)
A Cox proportional hazard model will be used to analyze the time to the first occurrence of the composite of death, non-fatal MI, or non-fatal stroke (MACE).
Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

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, 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)

September 17, 2019

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPOSITION

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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