Trial Title:
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
NCT ID:
NCT06229483
Condition:
Brain Tumor
Bleeding
Conditions: Official terms:
Hemorrhage
Tranexamic Acid
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
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
Intervention:
Intervention type:
Drug
Intervention name:
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Description:
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.
Arm group label:
Tranexamic Acid
Other name:
TXA
Intervention type:
Other
Intervention name:
Placebo
Description:
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.
Arm group label:
Matching Placebo
Other name:
Normal saline (0.9% sodium chloride)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nova Scotia Health Authority- Queen Elizabeth II Health Sciences Center
Address:
City:
Halifax
Zip:
B3H3A7
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Stephen Lownie, MD
Phone:
902-473-6449
Email:
stephen.lownie@nshealth.ca
Contact backup:
Last name:
Lisa Julien, RN BSCN CCRP
Phone:
902-473-3877
Email:
lisa.julien@nshealth.ca
Investigator:
Last name:
Sean Christie, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sean Barry, MD
Email:
Sub-Investigator
Investigator:
Last name:
Adrienne Weeks, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dan McNeely, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lutz Weise, MD
Email:
Sub-Investigator
Investigator:
Last name:
David Clarke, MD
Email:
Sub-Investigator
Investigator:
Last name:
Gwynedd Pickett, MD
Email:
Sub-Investigator
Investigator:
Last name:
Simon Walling, MD
Email:
Sub-Investigator
Investigator:
Last name:
Genevieve McKinnon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Suna Jung, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jacob Alant, MD
Email:
Sub-Investigator
Start date:
April 3, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Stephen Lownie
Agency class:
Other
Collaborator:
Agency:
Dalhousie University
Agency class:
Other
Source:
Nova Scotia Health Authority
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06229483
