The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

April 3, 2024 updated by: Stephen Lownie

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Recruiting
        • Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sean Christie, MD
        • Sub-Investigator:
          • Sean Barry, MD
        • Sub-Investigator:
          • Adrienne Weeks, MD
        • Sub-Investigator:
          • Dan McNeely, MD
        • Sub-Investigator:
          • Lutz Weise, MD
        • Sub-Investigator:
          • David Clarke, MD
        • Sub-Investigator:
          • Gwynedd Pickett, MD
        • Sub-Investigator:
          • Simon Walling, MD
        • Sub-Investigator:
          • Genevieve McKinnon, MD
        • Sub-Investigator:
          • Suna Jung, MD
        • Sub-Investigator:
          • Jacob Alant, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria are the following:

  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 are the following: Patients who meet any of the following exclusion criteria will not be eligible.

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • TXA
Placebo Comparator: 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.
Other: 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.
Other Names:
  • Normal saline (0.9% sodium chloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated intraoperative blood loss
Time Frame: Surgery
a. EBL (ml/kg) = ERCV lost (ml)/[weight (kg) x hematocrit preop/100] i. ERCV = EBV x hematocrit/100 ii. ERCV lost = ERCV preop + ERCV transfused - ERCV postop iii. ERCV transfused = PRBC transfused (ml) x hematocrit transfused PRBC/100 iv. EBV = 75 ml/kg x weight (kg) b. abbreviations used: EBL, estimated blood loss; ERCV, estimated red cell volume; EBV, estimated blood volume; PRBC, packed red blood cells
Surgery
Reoperation or disability or death due to intracranial hemorrhage within 30 days
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
What is the difference in Hemoglobin level postoperatively as compared to baseline?
Time Frame: 24 hrs
24 hrs
Number of subjects requiring transfusion of blood products
Time Frame: 30 days
30 days
Volume of transfused packed red blood cell (PRBC) and fresh frozen plasma (FFP)
Time Frame: 30 days
30 days
What is the difference in Intraoperative hemodynamics between subjects?
Time Frame: Surgery
Surgery
Length of operation
Time Frame: Surgery
Surgery
Length of intensive care unit (ICU)/hospital stay
Time Frame: 30 days
30 days
Medication related risks, including seizure, thromboembolic event
Time Frame: 30 days
30 days
What is the difference in Platelet level postoperatively as compared to baseline?
Time Frame: 24 hrs
24 hrs
What is the difference in Fibrinogen level postoperatively as compared to baseline?
Time Frame: 24 hrs
24 hrs
What is the difference in INR/PTT value level postoperatively as compared to baseline?
Time Frame: 24 hrs
24 hrs
What is the difference in Hematocrit level postoperatively as compared to baseline?
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephen Lownie

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Stephen Lownie, MD, Nova Scotia Health Authority- Queen Elizabeth II HSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TXA-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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