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Upon the Data Safety Monitoring Board review of the interim analysis (75% of participants have finished their follow-up) on November 17, 2023, they made a recommendation to stop recruitment into the trial.
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The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.
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 but to maintain the protection against bleeding. When TxA is used directly on the tissues (topically) for other type of surgeries (joints), TxA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TxA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Tranexamic Acid/Placebo | Active Comparator | Topical Tranexamic Acid 5g to 10g (50 to 100mL) or placebo. The topical will be poured into the pericardial and mediastinal cavities after protamine administration. |
|
| Intravenous Tranexamic Acid/Placebo | Active Comparator | Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients experiencing an in-hospital seizure | To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) is superior to the usual intravenous tranexamic acid administration for reducing the risk of in-hospital seizure. | Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients in-hospital who receive red blood cell transfusions | To determine in patients undergoing on-pump cardiac surgery, if topical tranexamic acid (intra-pericardial) compared with intravenous tranexamic acid administration is associated with a non-inferior risk of in-hospital red blood cell transfusion. | Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood product transfusions | Analyzed using an ANCOVA model. In such a model, bags of blood product will be included as a dependent variable, whereas dose of tranexamic acid and treatment will be included as covariates. | Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) |
| Re-operation for bleeding or tamponade |
Inclusion Criteria:
Exclusion Criteria:
Allergy to tranexamic acid
Undergoing minimally invasive surgery
Fulfill any of the following transfusion risk factors (A-D):
A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active)
History of previous cardiac surgery
Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
Pre-operative hemoglobin > 170 g/L or <110 g/L
Pre-operative thrombocytopenia (<50,000 platelets per µL)
Expected circulatory arrest
Pregnancy or breast feeding
Previously enrolled in the DEPOSITION trial
Refusal of blood products
Pericardiectomy
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| Name | Affiliation | Role |
|---|---|---|
| Andre Lamy, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelowna General Hospital | Kelowna | British Columbia | Canada | |||
| St. Boniface Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28858904 | Background | Spence J, Long S, Tidy A, Raymer K, Devereaux PJ, Lamy A, Whitlock R, Syed S. Tranexamic Acid Administration During On-Pump Cardiac Surgery: A Survey of Current Practices Among Canadian Anesthetists Working in Academic Centers. Anesth Analg. 2017 Dec;125(6):1863-1870. doi: 10.1213/ANE.0000000000002422. | |
| 21983111 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2026 | |
| Reset | Jun 24, 2026 |
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Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
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The pharmacy will prepare 2 syringes of 50 ml of topical TxA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TxA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.
|
Analyzed with a binomial regression |
| Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) |
| Duration of ICU stay | Analyzed using an ANCOVA model. | 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. |
| MACE (Death, non-fatal Myocardial Infarction (MI), or non-fatal stroke) | A Cox proportional hazard model will be used to analyze the time to the first occurrence of the composite of death, non-fatal MI, or non-fatal stroke (MACE). | Start of surgery to hospital discharge or 10 days maximum (whichever occurs first) |
| Winnipeg |
| Manitoba |
| R2H 2A6 |
| Canada |
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| Hamilton Health Sciences - General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| CHUM | Montreal | Ontario | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| CIUSSS NIM/Hôpital Sacré-Coeur de Montréal | Montreal | Quebec | Canada |
| IUCPQ | Québec | Quebec | Canada |
| Beijing Anzhen Hospital | Beijing | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| Nemocnice Agel Třinec | Třinec | Czechia |
| University of Malaya | Kuala Lumpur | Malaysia |
| Auckland City Hospital | Auckland | New Zealand |
| Petrovsky National Research Centre | Moscow | Russia |
| E.Meshalkin National Medical Research Center | Novosibirsk | Russia |
| Saint-Petersburg State University Hospital | Saint Petersburg | Russia |
| Lamy A, Tong W, Gao P, Chrolavicius S, Gafni A, Yusuf S, Connolly SJ. The cost of clopidogrel use in atrial fibrillation in the ACTIVE-A trial. Can J Cardiol. 2012 Jan-Feb;28(1):95-101. doi: 10.1016/j.cjca.2011.08.112. Epub 2011 Oct 8. |
| 30908754 | Result | Habbab LM, Hussain S, Power P, Bashir S, Gao P, Semelhago L, VanHelder T, Parry D, Chu V, Lamy A. Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION) study: Results of a pilot study. J Card Surg. 2019 May;34(5):305-311. doi: 10.1111/jocs.14027. Epub 2019 Mar 25. |
| 27774838 | Result | Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23. |
| 18480196 | Result | Fergusson DA, Hebert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussieres JS, Cote D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Clinch J, Pretorius R; BART Investigators. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med. 2008 May 29;358(22):2319-31. doi: 10.1056/NEJMoa0802395. Epub 2008 May 14. |
| 30146969 | Result | Mazer CD, Whitlock RP, Fergusson DA, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, Carrier FM, McGuinness S, Young PJ, Byrne K, Villar JC, Royse A, Grocott HP, Seeberger MD, Mehta C, Lellouche F, Hare GMT, Painter TW, Fremes S, Syed S, Bagshaw SM, Hwang NC, Royse C, Hall J, Dai D, Mistry N, Thorpe K, Verma S, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. N Engl J Med. 2018 Sep 27;379(13):1224-1233. doi: 10.1056/NEJMoa1808561. Epub 2018 Aug 26. |
| 22054656 | Result | Kalavrouziotis D, Voisine P, Mohammadi S, Dionne S, Dagenais F. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg. 2012 Jan;93(1):148-54. doi: 10.1016/j.athoracsur.2011.07.085. Epub 2011 Nov 4. |
| 38587333 | Derived | Lamy A, Sirota DA, Jacques F, Poostizadeh A, Noiseux N, Efremov S, Demers P, Akselrod B, Wang CY, Arora RC, Branny P, McGuinness SP, Brown CD, Jeanmart H, Zhao Q, Zhang H, Belley-Cote EP, Whitlock RP, Browne A, Copland I, Vincent J, Khatun R, Balasubramanian K, Bangdiwala SI, McGillion MH, Fox-Robichaud AE, Spence J, Yusuf S, Devereaux PJ; DEPOSITION Study Group. Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial. Circulation. 2024 Oct 22;150(17):1315-1323. doi: 10.1161/CIRCULATIONAHA.124.069606. Epub 2024 Apr 8. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2026 | Jun 24, 2026 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D016063 | Blood Loss, Surgical |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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