Bleeding, Colorectal Disorders, Thromboembolism, Tranexamic Acid
Conditions
Keywords
Tranexamic Acid, TXA, Bleeding, Colorectal Surgery, Thromboembolism
Brief summary
The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are: * Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days) * Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding) * Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism) Researchers will compare preoperative TXA to no TXA to answer the above questions. Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.
Interventions
DRUGTranexamic acid
1 gram IV bolus in 100ml of normal saline administered over 10 minutes at the start and end of the surgery for a total of 2 grams TXA
Sponsors
Kristen Ban
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Pragmatic (non-blinded)
Intervention model description
Intervention (TXA) and control (no TXA) cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Adults 18 years or older 2. Undergoing elective or non-elective inpatient abdominal and pelvic colorectal surgery
Exclusion criteria
1. Creatinine clearance less than 30 mL/minute 2. Long-term dialysis 3. Known defective color vision (color blind) 4. Pregnancy 5. History of venous or arterial thromboembolism, or active thromboembolic disease 6. Disseminated intravascular coagulation (DIC) - clinically suspected and/or confirmed by platelet count on CBC, fibrinogen, INR and PTT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative change in hemoglobin | 60 days | Preoperative to lowest postoperative within 30 days of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of composite bleeding complication | Within 30 days postop | Bleeding requiring transfusion, bleeding prompting medication to be held for DVT prophylaxis or therapeutic anticoagulation, bleeding requiring return to the operating room or procedural intervention, mortality secondary to bleeding |
| Rate of composite thromboembolic event | Within 30 days postop | Thromboembolic cerebrovascular accident (CVA), myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE) |
Countries
United States
Contacts
CONTACTKristen A Ban, MD MS
PRINCIPAL_INVESTIGATORKristen A Ban, MD MS
The Cleveland Clinic
Outcome results
None listed