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Tranexamic Acid

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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.

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.

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

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.

Placebo

Stephen Lownie, MD

Lisa Julien, RN BScN

Lisa Julien, RN BSCN CCRP

Sean Christie, MD

Sean Barry, MD

Adrienne Weeks, MD

Dan McNeely, MD

Lutz Weise, MD

David Clarke, MD

Gwynedd Pickett, MD

Simon Walling, MD

Genevieve McKinnon, MD

Suna Jung, MD

Jacob Alant, MD

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.

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.

Participants will be randomized to receive a 20 mg/kg IV bolus of TXA, or identical volume of placebo 0.9 % NaCl will be administered intravenously push by the anesthesiologist approximately 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

This is a blinded study. The participant, surgeon and research team will not know the treatment allocation. Only the pharmacy preparing the medication will be unblinded

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

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

Dalhousie University

Stephen Lownie

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies	NCT06229483	Brain Tumor Bleeding	TRANEXAMIC ACID... Placebo	18 Years - 80 Years	Nova Scotia Health Authority
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies	NCT06229483	Brain Tumor Bleeding	TRANEXAMIC ACID... Placebo	18 Years - 80 Years	Nova Scotia Health Authority

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