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Tranexamic Acid for Bleeding After Heart Surgery (DEPOSITION Trial)
DEPOSITION Trial Summary
This trial will compare the use of a topical form of tranexamic acid to the usual intravenous form in patients undergoing heart surgery.
- Seizures
- Bleeding
- Blood Loss
DEPOSITION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DEPOSITION Trial Design
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Who is running the clinical trial?
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- You are allergic to tranexamic acid.You are having a type of surgery that is not very invasive.You have had emergency surgery, a history of bleeding disorder, an inherited blood clotting or bleeding disease, or active infective endocarditis.You do not want to receive blood transfusions.You have had surgery to remove the pericardium.You are 18 years old or older.Your kidneys are not working well, and you have a low estimated glomerular filtration rate or you are on dialysis.You have a low number of platelets in your blood before surgery.You recently had heart surgery involving the use of a heart-lung machine and an incision in the middle of your chest.You have had heart surgery in the past.Your hemoglobin levels are either too high (above 170 g/L) or too low (below 110 g/L) before surgery.There is a high chance of having a stop in blood circulation.
- Group 1: Topical Tranexamic Acid/Placebo
- Group 2: Intravenous Tranexamic Acid/Placebo
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other investigations have sought to determine the efficacy of this treatment?
"Presently, there are 61 medical trials in progress analyzing this therapeutic intervention with 26 of the studies having reached Phase 3. Several sites for these clinical tests can be found within Kansas City, but overall 185 research centres across America are engaged in testing for it."
How many participants are currently in the clinical trial?
"This trial necessitates 3,800 participants who meet the pre-defined requirements. For those interested in participating, there are locations at IUCPQ in Quebec City and Kelowna General Hospital in Kelowna available for enrolment."
What is the safety profile of this particular therapy?
"A score of 3 has been awarded to this treatment's safety due to the Phase 4 trial, which confirms its approval."
Are there any open opportunities to participate in this research project?
"Affirmative, the information on clinicaltrials.gov specifies that this study is actively enrolling participants. The trial was initially posted in September of 2019 and amended most recently on August 5th 2022. A total of 3800 patients from 4 distinct sites are required for participation."
Are there numerous establishments conducting this research in Canada?
"This trial is accessible to patients in 4 different centres, including IUCPQ in Quebec City, Kelowna General Hospital in Kelowna and CHUM in Montreal. Additional sites are available as well."
For what kinds of conditions is this therapy typically prescribed?
"This therapeutic approach is often used to manage hyperfibrinolysis, as well as several other medical issues like hemophilia and bleeding following a tooth extraction."
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