Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery

Study Overview
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Brief Summary
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A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking surgery for colorectal cancer will be randomized into two equal groups one will receive tranexamic acid and one placebo. The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision. In the control group, patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is reduction in blood loss, while the secondary endpoint was the number of patients needing transfusion and occurrence of postoperative thrombotic complications (myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.

Official Title
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Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid Injection
* Drug: placebo injection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria ASA 1 and ASA 2 patients scheduled for colorectal cancer surgery. Age above 18 years & less than 65 years. Exclusion criteria: Thrombophilia or any bleeding disorder. Previous or active thromboembolic disease. Family history of thromboembolism. Known Allergy to TA. Liver dysfunction. Preexisting renal dysfunction (serum creatinine >1.2 mg/dL). Coronary stent insertion within a year prior to operation. Cardiovascular problem (e.g., myocardial infarction, atrial fibrillation, angina, heart failure), Lifelong warfarin therapy for thromboembolism prophylaxis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid group<br> | Drug: Tranexamic Acid Injection<br>* The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision<br>|
| Placebo Comparator: placebo group<br> | Drug: placebo injection<br>* patients will receive a placebo of 100 mL 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in blood loss | Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).The amount of drained blood will be measured in 1st 24 hours. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal,blood, transfusion,haemorrhage,tranexamic acid.