NCT03646474

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

Evaluation of the Efficacy & Safety of a Single Dose Tranexamic Acid in Reducing Blood Loss During Cytoreductive Surgery and HIPEC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytoreductive Surgery

Interventions

Type	Name	Description
DRUG	tranexamic Acid infusion	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.
DRUG	saline infusion	In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.

Timeline

• Start date: 2018-08-30
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2018-08-24
• Last updated: 2022-06-07

Locations

1 site across 1 country: Egypt