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NCT Number: NCT06229483

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H3A7, Canada

Location status: Recruiting

Location contact

Adrienne Weeks, MD

SUB_INVESTIGATOR

Dan McNeely, MD

SUB_INVESTIGATOR

David Clarke, MD

SUB_INVESTIGATOR

Genevieve McKinnon, MD

SUB_INVESTIGATOR

Gwynedd Pickett, MD

SUB_INVESTIGATOR

Jacob Alant, MD

SUB_INVESTIGATOR

Lisa Julien, RN BSCN CCRP

CONTACT

[email protected]

902-473-3877

Lutz Weise, MD

SUB_INVESTIGATOR

Sean Barry, MD

SUB_INVESTIGATOR

Sean Christie, MD

SUB_INVESTIGATOR

Simon Walling, MD

SUB_INVESTIGATOR

Stephen Lownie, MD

CONTACT

[email protected]

902-473-6449

Suna Jung, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

are the following:

  • Adult male or female, between 18-80 years of age.
  • Patients are scheduled to undergo a craniotomy for tumor resection.
  • 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.

  • Patients with known active or previous history of thromboembolic disease or deep venous thrombosis.
  • Patients with known pre-existing coagulopathy such as hemophilia, Von Willebrand disease, and clotting factor deficiencies.
  • 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.
  • Female subjects who are pregnant or currently breastfeeding.
  • Patients with Class 3 (high-risk) obesity BMI ≥ to 40.
  • Patients undergoing emergency craniotomy or mini craniotomy or craniectomies.
  • Patients who received embolization prior to surgery.

Treatment and study plan

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

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.

Other names: TXA

Placebo

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.

Other names: Normal saline (0.9% sodium chloride)

Primary outcomes

  1. 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

  2. Reoperation or disability or death due to intracranial hemorrhage within 30 days

    Time frame: 30 days

Secondary outcomes

  1. What is the difference in Hemoglobin level postoperatively as compared to baseline?

    Time frame: 24 hrs

  2. Number of subjects requiring transfusion of blood products

    Time frame: 30 days

  3. Volume of transfused packed red blood cell (PRBC) and fresh frozen plasma (FFP)

    Time frame: 30 days

  4. What is the difference in Intraoperative hemodynamics between subjects?

    Time frame: Surgery

  5. Length of operation

    Time frame: Surgery

  6. Length of intensive care unit (ICU)/hospital stay

    Time frame: 30 days

  7. Medication related risks, including seizure, thromboembolic event

    Time frame: 30 days

  8. What is the difference in Platelet level postoperatively as compared to baseline?

    Time frame: 24 hrs

  9. What is the difference in Fibrinogen level postoperatively as compared to baseline?

    Time frame: 24 hrs

  10. What is the difference in INR/PTT value level postoperatively as compared to baseline?

    Time frame: 24 hrs

  11. What is the difference in Hematocrit level postoperatively as compared to baseline?

    Time frame: 24 hrs

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Julien, RN BScN

CONTACT

[email protected]

902-473-3877

Stephen Lownie, MD

CONTACT

[email protected]

902-473-6449

Sponsors and collaborators

Lead sponsor

Stephen Lownie

Other

Collaborators

  • Dalhousie University

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 29, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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