Tranexamic Acid Timing for Postoperative Bleeding (DEPOSITION-2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Hamilton Health Sciences Corporation
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this 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.
Eligibility Criteria
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.Inclusion Criteria
I am 18 years old or older.
I am having heart surgery that requires a heart-lung machine.
Exclusion Criteria
I refuse blood transfusions due to personal beliefs.
I have a high risk of bleeding due to conditions like emergency surgery, bleeding disorders, or low blood counts.
My kidney function is very low or I am on dialysis.
I have had surgery to remove part or all of my heart's sac.
Participant Groups
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.
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.
Tranexamic Acid is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇪🇺 Approved in European Union as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Hereditary angioedema
🇨🇦 Approved in Canada as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇯🇵 Approved in Japan as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
🇦🇺 Approved in Australia as Tranexamic Acid for:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Hamilton Health Sciences - General HospitalHamilton, Canada
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Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor