The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

Phase 3

Recruiting

• Conditions: Brain Tumor; Bleeding
• Interventions: Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION; Other: Placebo

• Registration Number: NCT06229483
• Lead Sponsor: Stephen Lownie

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.

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Status Verified: 2024-04
• Study Start: 2024-04-03
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION	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.
Matching Placebo	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.

Primary Outcome Measures

Name	Time	Method
Estimated intraoperative blood loss	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
Reoperation or disability or death due to intracranial hemorrhage within 30 days	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada