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

Not Applicable

Completed

• Conditions: Cytoreductive Surgery
• Interventions: Drug: saline infusion; Drug: tranexamic Acid infusion

• Registration Number: NCT03646474
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2018-08-30
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	saline infusion	-
tranexamic acid group	tranexamic Acid infusion	-

Primary Outcome Measures

Name	Time	Method
change in blood loss	1st 24 hours.	Blood loss will be calculated (volume estimated as the blood remaining in sponges and drapes and the volume in suction bottles during surgery).

Trial Locations

Locations (1)

National Cancer Institute, Cairo University; 🇪🇬 Cairo, Egypt