The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

NCT ID: NCT06229483

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-03
• Study Completion Date: 2027-12-31

Brief Summary

The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are:

1. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery?

2. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

Detailed Description

Excessive blood loss during and after a neurosurgical procedure may increase illness and cause death. The surgeons and their team put in a lot of effort during surgery to and prevent excessive bleeding during and after surgery. One of the medications that may help is tranexamic acid (TXA). TXA is a medication that is widely used in cardiac, orthopedic and trauma surgery to prevent heavy bleeding, the need for blood transfusion and reduce death. During neurosurgery, there is not enough proof whether giving TXA to participants reduces blood loss, and there are no clear guidelines regarding the use of TXA. Investigators are interested in studying the effect of TXA on blood loss in participants undergoing craniotomy to remove a brain tumor. A craniotomy is an operation where a piece of the skull is removed to show part of the brain to remove a brain tumor. One of the risks associated with this procedure is bleeding. Currently, some participants undergoing this type of surgery receive TXA and others do not, as the decision to administer TXA is based on an investigator's preference. Therefore, a study investigating the impact of TXA on bleeding during or following craniotomy, as well as its safety, is needed to better inform practice and potentially improve outcomes of surgery.

Conditions

Brain Tumor; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tranexamic Acid

Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.

Group Type: EXPERIMENTAL

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

Intervention Type: DRUG

Tranexamic acid 20 mg/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, for the duration of surgery. Treatment is blinded.

Matching Placebo

Participants will be randomized in a 1:1 ratio to receive tranexamic acid 20 mg/kg IV bolus or identical volume of placebo 0.9 % NaCl within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, or identical volume of placebo 0.9 % NaCl, for the duration of surgery. Treatment is blinded.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.9% normal saline 20ml/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml/kg/hr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.

Interventions

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

Tranexamic acid 20 mg/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 mg/kg/hr infusion of TXA, for the duration of surgery. Treatment is blinded.

Intervention Type: DRUG

Placebo

0.9% normal saline 20ml/kg IV bolus within 30 minutes prior to the skin incision followed by a 1 ml/kg/hr infusion of 0.9 % sodium chloride for the duration of surgery. Treatment is blinded.

Intervention Type: OTHER

Other Intervention Names

TXA; Normal saline (0.9% sodium chloride)

Eligibility Criteria

Inclusion Criteria

1. Adult male or female, between 18-80 years of age.

2. Patients are scheduled to undergo a craniotomy for tumor resection.

3. Patients/ Substitute Decision Maker have given written consent to participate.

Exclusion Criteria

1. Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.

2. Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.

3. Patients with renal impairment and eGFR <60 ml/min/1.73 m2 as determined by the lab or calculated by using the Cockcroft Gault formula or end stage renal disease currently on dialysis.

4. Female subjects who are pregnant or currently breastfeeding.

5. Patients with Class 3 (high-risk) obesity BMI ≥ to 40.

6. Patients undergoing emergency craniotomy or mini craniotomy or craniectomies.

7. Patients who received embolization prior to surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Stephen Lownie

OTHER

Sponsor Role: lead

Responsible Party

Stephen Lownie

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephen Lownie, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority- Queen Elizabeth II HSC

Locations

Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Stephen Lownie, MD

Role: CONTACT

stephen.lownie@nshealth.ca

902-473-6449

Lisa Julien, RN BScN

Role: CONTACT

lisa.julien@nshealth.ca

902-473-3877

Facility Contacts

Stephen Lownie, MD

Role: primary

stephen.lownie@nshealth.ca

902-473-6449

Lisa Julien, RN BSCN CCRP

Role: backup

lisa.julien@nshealth.ca

902-473-3877

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

Reference Type: RESULT

PMID: 20554319 (View on PubMed)

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Reference Type: RESULT

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Other Identifiers

TXA-2024-01

Identifier Type: -

Identifier Source: org_study_id