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Completed

NCT Number: NCT03376061

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.

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Key information

Conditions

Bleeding Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Blood Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Tranexamic Acid

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants With Seizures

    Time frame: Patients will be followed post-operatively until hospital discharge

    Patients experiencing a post-operative seizure

  2. Number of Participants With Mortality

    Time frame: Patients will be followed post-operatively until hospital discharge

    The occurrence of death due to any cause

  3. Number of Participants With RBC Transfusion

    Time frame: Intra-operative and post-operative RBC transfusions

    Patients requiring a red blood cell transfusion

  4. 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

  5. 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)

  6. 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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: DEPOSITION

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 18, 2017
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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