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Anti-fibrinolytic agent

Tranexamic Acid Timing for Postoperative Bleeding (DEPOSITION-2 Trial)

Phase 3

Waitlist Available

Led By Andre Lamy, MD

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Undergoing a cardiac surgical procedure with the use of cardiopulmonary bypass (i.e., isolated CABG, isolated single cardiac valve surgery, or a combination of both, or isolated ascending aorta replacement)

Must not have

Refusal of blood products (e.g., Jehovah's Witnesses)

Fulfill any of the following transfusion risk factors: Emergency surgery, History of bleeding disorder, Inherited thromboembolic or hemorrhagic disease, Active infective endocarditis, Pre-operative thrombocytopenia (<50,000 platelets per µL), Pre-operative hemoglobin <110 g/L

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of enrollment (date of first patient) to end of enrollment (date of last patient).

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if giving tranexamic acid before or after heart surgery affects its concentration in the blood and its ability to break down blood clots. They want to determine if a larger study

Who is the study for?

This trial is for individuals undergoing cardiac surgery who are willing to provide informed consent, receive tranexamic acid during their operation, and give blood samples at specified times before and after the surgery. Specific eligibility criteria have not been detailed.

What is being tested?

The study tests whether giving intravenous tranexamic acid before or after cardiopulmonary bypass affects blood loss and seizure rates post-surgery. It's a pilot study to see if a larger trial would be feasible and will measure drug levels in the blood.

What are the potential side effects?

While specific side effects aren't listed, tranexamic acid can generally cause nausea, diarrhea, muscle cramps or pain. In some cases, it may increase the risk of seizures or cause allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am having heart surgery that requires a heart-lung machine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I refuse blood transfusions due to personal beliefs.

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I have a high risk of bleeding due to conditions like emergency surgery, bleeding disorders, or low blood counts.

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My kidney function is very low or I am on dialysis.

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I have had surgery to remove part or all of my heart's sac.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure the level of plasma TxA at 5 time points

Secondary study objectives

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

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

Other study objectives

Duration of intensive care unit stay

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

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

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: After CPB Tranexamic Acid/PlaceboActive Control2 Interventions

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 II: Before CPB Tranexamic Acid/PlaceboActive Control2 Interventions

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.

0 / 6Eligibility criteria met