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NCT Number: NCT06622564

Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are:

* Is it feasible to conduct a larger definitive trial? * Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples?

Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better.

Participants will:

* Provide written informed consent * Receive tranexamic acid during surgery * Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.

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Key information

Conditions

Bleeding Blood Loss, Surgical Hemorrhage Intraoperative Complications Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Surgical Blood Loss

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location contact

Patricia Power

CONTACT

[email protected]

905-527-4322 ext. 44495

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 (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 and to improve the protection against bleeding. When TxA is used before and during cardiopulmonary bypass (CPB), the presence of systemic TxA during de-airing of the heart and the termination of CPB may facilitate entry of TxA into the brain causing seizures. Administration of TxA after CPB may result in higher systemic concentrations that may be more effective for protecting against bleeding after surgery. The aim is to establish the feasibility of a definitive trial to prove that administration of TxA after CPB 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

  • ≥18 years of age
  • Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
  • Provide written informed consent

Exclusion criteria

  • Allergy to tranexamic acid
  • Fulfill any of the following transfusion risk factors (A-F):

A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active) E. Pre-operative thrombocytopenia (<50,000 platelets per µL) F. Pre-operative hemoglobin <110 g/L

  • Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
  • Pre-operative hemoglobin >170 g/L
  • Expected circulatory arrest
  • Pregnancy or breast feeding
  • Previous enrollment in DEPOSITION trial
  • Refusal of blood products (e.g., Jehovah's Witnesses)
  • Isolated Pericardiectomy

Treatment and study plan

Before CPB Tranexamic Acid

Drug

Tranexamic acid 1 to 10 g (10 to 100 mL) administered intravenously as per standard care at the induction of anesthesia as a bolus and/or continuous infusion (i.e., before CPB).

Other names: Cyklokapron

After CPB Tranexamic Acid

Drug

Tranexamic acid 5 g (50 mL) administered after heparin reversal (i.e., after CPB).

Other names: Cyklokapron

Before CPB Placebo

Drug

Placebo (10 to 100 mL saline) administered intravenously at the induction of anesthesia as a bolus and/or continuous infusion.

Other names: Saline

After CPB Placebo

Drug

Placebo (50 mL saline) administered after heparin reversal.

Other names: Saline

Primary outcomes

  1. Measure the level of plasma TxA at 5 time points

    Time frame: From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

    Measure the level of plasma TxA at 5 time points: pre-operative, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

Secondary outcomes

  1. Measure the clot lysis time (i.e., fibrinolytic activity) at 5 time points

    Time frame: From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

    Measure the clot lysis time (i.e., fibrinolytic activity) at 5 time points: pre-operative baseline, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

  2. Measure the plasmin generation (i.e., fibrinolytic activity) at 5 time points

    Time frame: From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

    Measure the plasmin generation (i.e., fibrinolytic activity) at 5 time points: pre-operative baseline, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

Other outcomes

  1. Feasibility outcome (study-level): mean enrollment rate of the study

    Time frame: Start of enrollment (date of first patient) to end of enrollment (date of last patient).

    Determine whether the mean enrolment rate of the trial (total number of patients recruited / total recruitment period in weeks) is 2 patients per week or more.

  2. Feasibility outcome (study-level): crossover rate of the study

    Time frame: Start of enrollment (date of first patient) to end of enrollment (date of last patient).

    Determine whether the percentage of crossovers between groups (total number of patients with crossover / total number of patients recruited * 100) is less than 5%.

  3. Feasibility outcome (study-level): percentage of data completion of the study

    Time frame: Start of enrollment (date of first patient) to end of enrollment (date of last patient).

    Determine whether the percentage of data completion (total number of patients with complete outcome data / total number of patients enrolled * 100) is more than 95%.

  4. Proportion of patients experiencing an in-hospital seizure

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

  5. Proportion of patients requiring any blood product transfusion

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

  6. Proportion of patients requiring re-operation for bleeding or cardiac tamponade

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

  7. Proportion of patients requiring a red blood cell transfusion

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

  8. Proportion of patients requiring pericardiocentesis

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

  9. Duration of intensive care unit 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.

    Appropriate descriptive statistics will be provided.

  10. Proportion of patients experiencing the composite outcome of death, non-fatal myocardial infarction, or stroke

    Time frame: Start of surgery to hospital discharge or 10 days maximum (whichever occurs first)

    Appropriate descriptive statistics will be provided.

Study contacts

Contact information is provided by the study sponsor or research team.

Austin Browne

CONTACT

[email protected]

905-527-4322 ext. 40582

Patricia Power

CONTACT

[email protected]

905-527-4322 ext. 44495

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION)-2 Pilot Trial

Acronym: DEPOSITION-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

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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