MedDataX Logo

DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

NCT ID: NCT03954314

Last Updated: 2023-12-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2023-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bleeding Surgical Blood Loss Seizures

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tranexamic Acid On-pump Cardiac Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Topical Tranexamic Acid/Placebo

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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type 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.

Intravenous Tranexamic Acid/Placebo

Intravenous Tranexamic Acid 1 to 10g (10 to 100mL) or placebo administered intravenously at the induction of anesthesia as a bolus-infusion.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tranexamic Acid

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyklokapron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. ≥ 18 years of age
2. Undergoing a cardiac surgical procedure (i.e. isolated coronary artery bypass graft (CABG), isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy
3. Provide written informed consent

Exclusion Criteria

1. Allergy to tranexamic acid
2. Undergoing minimally invasive surgery
3. 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)
4. History of previous cardiac surgery
5. Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
6. Pre-operative hemoglobin \> 170 g/L or \<110 g/L
7. Pre-operative thrombocytopenia (\<50,000 platelets per µL)
8. Expected circulatory arrest
9. Pregnancy or breast feeding
10. Previously enrolled in the DEPOSITION trial
11. Refusal of blood products
12. Pericardiectomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andre Lamy, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kelowna General Hospital

Kelowna, British Columbia, Canada

Site Status

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, Canada

Site Status

CHUM

Montreal, Ontario, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

CIUSSS NIM/Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Site Status

IUCPQ

Québec, Quebec, Canada

Site Status

Beijing Anzhen Hospital

Beijing, , China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Nemocnice Agel Třinec

Třinec, , Czechia

Site Status

University of Malaya

Kuala Lumpur, , Malaysia

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Petrovsky National Research Centre

Moscow, , Russia

Site Status

E.Meshalkin National Medical Research Center

Novosibirsk, , Russia

Site Status

Saint-Petersburg State University Hospital

Saint Petersburg, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada China Czechia Malaysia New Zealand Russia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28858904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21983111 (View on PubMed)

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.

Reference Type RESULT
PMID: 30908754 (View on PubMed)

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.

Reference Type RESULT
PMID: 27774838 (View on PubMed)

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.

Reference Type RESULT
PMID: 18480196 (View on PubMed)

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.

Reference Type RESULT
PMID: 30146969 (View on PubMed)

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.

Reference Type RESULT
PMID: 22054656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38587333 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEPOSITION

Identifier Type: -

Identifier Source: org_study_id