Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

NCT06622564 | Not Yet Recruiting Phase 3

• 1 other identifier: DEPOSITION-2_2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bleeding; Surgical Blood Loss; Seizures

Keywords

cardiac surgery; tranexamic acid; cardiopulmonary bypass; seizure; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Measure the level of plasma TxA at 5 time points

  Measure the level of plasma TxA at 5 time points: pre-operative, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

  From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

Secondary Outcomes (2)

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

  From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

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

  From baseline to on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.

Other Outcomes (10)

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

  Start of enrollment (date of first patient) to end of enrollment (date of last patient).

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

  Start of enrollment (date of first patient) to end of enrollment (date of last patient).

• Feasibility outcome (study-level): percentage of data completion of the study

  Start of enrollment (date of first patient) to end of enrollment (date of last patient).

Study Arms (2)

After CPB Tranexamic Acid/Placebo

ACTIVE COMPARATOR

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).

Drug: After CPB Tranexamic Acid; Drug: Before CPB Placebo

Before CPB Tranexamic Acid/Placebo

ACTIVE COMPARATOR

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.

Drug: Before CPB Tranexamic Acid; Drug: After CPB Placebo

Interventions

Before CPB Tranexamic Acid DRUG

Tranexamic acid 1 to 10 g (10 to 100 mL) administered intravenously as per standard care at the induction of anesthesia as a bolus and/or continuous infusion (i.e., before CPB).

Also known as: Cyklokapron

Before CPB Tranexamic Acid/Placebo

After CPB Tranexamic Acid DRUG

Tranexamic acid 5 g (50 mL) administered after heparin reversal (i.e., after CPB).

Also known as: Cyklokapron

After CPB Tranexamic Acid/Placebo

Before CPB Placebo DRUG

Placebo (10 to 100 mL saline) administered intravenously at the induction of anesthesia as a bolus and/or continuous infusion.

Also known as: Saline

After CPB Tranexamic Acid/Placebo

After CPB Placebo DRUG

Placebo (50 mL saline) administered after heparin reversal.

Also known as: Saline

Before CPB Tranexamic Acid/Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
• Provide written informed consent

You may not qualify if:

• Allergy to tranexamic acid
• Fulfill any of the following transfusion risk factors (A-F):
• A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active) E. Pre-operative thrombocytopenia (\<50,000 platelets per µL) F. Pre-operative hemoglobin \<110 g/L
• Estimated glomerular filtration rate \<30 mL/min (CKD-EPI equation) or on dialysis
• Pre-operative hemoglobin \>170 g/L
• Expected circulatory arrest
• Pregnancy or breast feeding
• Previous enrollment in DEPOSITION trial
• Refusal of blood products (e.g., Jehovah's Witnesses)
• Isolated Pericardiectomy

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

• 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.

  PMID: 30908754 BACKGROUND

• 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.

  PMID: 38587333 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Blood Loss, Surgical; Seizures

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andre Lamy, MD

  Hamilton General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Austin Browne

CONTACT

905-527-4322; austin.browne@phri.ca

Patricia Power

CONTACT

905-527-4322; powerpat@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After CPB Tranexamic Acid + Before CPB Placebo versus Before CPB Tranexamic Acid + After CPB Placebo

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)