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

NCT ID: NCT03606785

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-05
• Study Completion Date: 2020-01-31

Brief Summary

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.

Conditions

Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tranexamic acid group

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid Injection

Intervention Type: DRUG

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

placebo group

Group Type: PLACEBO_COMPARATOR

placebo injection

Intervention Type: DRUG

patients will receive a placebo of 100 mL 0.9% normal saline

Interventions

Tranexamic Acid Injection

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

Intervention Type: DRUG

placebo injection

patients will receive a placebo of 100 mL 0.9% normal saline

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed H Othman

Assisstant professor of Anesthesia ICU and pain Relief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NCI, Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

201617010.2P

Identifier Type: -

Identifier Source: org_study_id