Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

Assiut University

Status: Completed

Conditions: Cytoreductive Surgery

Treatments: Drug: tranexamic Acid infusion; Drug: saline infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03646474

201617027.2p

Details and patient eligibility

About

The Tranexamic Acid 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

tranexamic acid group

Active Comparator group

Treatment:

Drug: tranexamic Acid infusion

placebo group

Placebo Comparator group

Treatment:

Drug: saline infusion