The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStephen Lownie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
DrugTranexamic 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.
Placebo
Other intervention0.9% 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Tranexamic AcidExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Estimated intraoperative blood loss
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
Time frame
Surgery2
Reoperation or disability or death due to intracranial hemorrhage within 30 days
Time frame
30 daysSecondary outcomes
1
What is the difference in Hemoglobin level postoperatively as compared to baseline?
Time frame
24 hrs2
Number of subjects requiring transfusion of blood products
Time frame
30 days3
Volume of transfused packed red blood cell (PRBC) and fresh frozen plasma (FFP)
Time frame
30 days4
What is the difference in Intraoperative hemodynamics between subjects?
Time frame
SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Stephen Lownie
Lead sponsor
Nova Scotia Health Authority
Sponsor institution
Dalhousie University
Collaborator
Source ClinicalTrials.gov