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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bleeding Surgical Blood Loss Seizures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After CPB Tranexamic Acid + Before CPB Placebo versus Before CPB Tranexamic Acid + After CPB Placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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After CPB Tranexamic Acid/Placebo

In the intervention group, patients will receive intravenous administration (10-100 mL of saline placebo) at the induction of anesthesia as a bolus and/or continuous infusion. In addition, patients will receive intravenous administration (5 g of TxA) after heparin reversal (i.e., after CPB).

Group Type ACTIVE_COMPARATOR

After CPB Tranexamic Acid

Intervention Type DRUG

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

Before CPB Placebo

Intervention Type DRUG

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

Before CPB Tranexamic Acid/Placebo

In the control group, patients will receive an intravenous administration (1-10 g of TxA) at the induction of anesthesia as a bolus and/or continuous infusion (i.e., before CPB). In addition, patients will receive an intravenous administration (50 mL of saline placebo) after heparin reversal.

Group Type ACTIVE_COMPARATOR

Before CPB Tranexamic Acid

Intervention Type 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).

After CPB Placebo

Intervention Type DRUG

Placebo (50 mL saline) administered after heparin reversal.

Interventions

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Before CPB Tranexamic Acid

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).

Intervention Type DRUG

After CPB Tranexamic Acid

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

Intervention Type DRUG

Before CPB Placebo

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

Intervention Type DRUG

After CPB Placebo

Placebo (50 mL saline) administered after heparin reversal.

Intervention Type DRUG

Other Intervention Names

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Cyklokapron Cyklokapron Saline Saline

Eligibility Criteria

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Inclusion Criteria

1. ≥18 years of age
2. 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
3. Provide written informed consent

Exclusion Criteria

1. Allergy to tranexamic acid
2. 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
3. Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
4. Pre-operative hemoglobin \>170 g/L
5. Expected circulatory arrest
6. Pregnancy or breast feeding
7. Previous enrollment in DEPOSITION trial
8. Refusal of blood products (e.g., Jehovah's Witnesses)
9. Isolated Pericardiectomy

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No