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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | TXA administered as a 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 |
|
| Control (no tranexamic acid) | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative change in hemoglobin | Preoperative to lowest postoperative within 30 days of surgery | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of composite bleeding complication | 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 | Within 30 days postop |
| Rate of composite thromboembolic event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen A Ban, MD MS | Contact | 2164766961 | bank4@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Kristen A Ban, MD MS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Fairview Hospital | Recruiting | Cleveland | Ohio | 44111 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Intervention (TXA) and control (no TXA) cohorts
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Pragmatic (non-blinded)
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Thromboembolic cerebrovascular accident (CVA), myocardial infarction (MI), deep venous thrombosis (DVT), pulmonary embolism (PE) |
| Within 30 days postop |
| D002318 | Cardiovascular Diseases |