Bleeding, Brain Tumor
Conditions
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.
Interventions
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.
OTHERPlacebo
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.
Sponsors
Stephen Lownie
Dalhousie University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| What is the difference in Hemoglobin level postoperatively as compared to baseline? | 24 hrs |
| Number of subjects requiring transfusion of blood products | 30 days |
| 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 operation | 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 |
Countries
Canada
Contacts
CONTACTStephen Lownie, MD
CONTACTLisa Julien, RN BScN
PRINCIPAL_INVESTIGATORStephen Lownie, MD
Nova Scotia Health Authority- Queen Elizabeth II HSC
Outcome results
None listed