NCT03070847

Low vs. Very Low Dose of Prophylactic Tranexamic Acid for Bleeding Reduction During Rhinoplasty

Impact of Prophylactic Tranexamic Acid on Intra and Postoperational Bleeding Reduction in Patients Undergoing Rhinoplasty Surgery. Low (10mg/kg) and Very Low (5mg/kg) Dose Comparison

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bartłomiej Wódarski · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether very low dose of preoperative tranexamic acid (5mg/kg) is as effective as low dose (10mg/kg) for intraoperational bleeding reduction in patients undergoing elective rhinoplasty surgery.

Detailed description

Background Tranexamic acid is a drug registered for bleeding prevention and reduction. It is on the World Health Organisation (WHO) 'essential drugs list'. Preoperative tranexamic acid efficacy is well proved for doses between 10 and 40 mg/kg and last years and decades publications showed that 'low dose' (10mg/kg) is as efficient as higher doses but connected with less adverse effects. Objectives To determine whether 5 mg/kg dose is as effective as commonly used 10mg/kg dose in intraoperational bleeding reduction. Methodology All patients would be randomised into one of two arms - low and very low dose. Patients, investigators and caregivers would be blinded. Patients would receive intravenous bolus of tranexamic acid at 15 minutes before admission to operation theatre in a dose dependent on the study arm. General, intravenous anesthesia (total intravenous anesthesia) would be performed due to hospital standards. At the end of the surgery total blood volume and adverse effects would be noted. Surgeon would asses surgical field in the Fromm scale. The survey is planned for a two years timespan or until 50 patients have enrolled (25 for each arm).

Conditions

• Bleeding Reduction

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Dose: 5mg/kg
DRUG	Tranexamic Acid	Dose: 10mg/kg
DRUG	Sodium Chloride	Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2017-03-06
• Last updated: 2017-08-30

Locations

1 site across 1 country: Poland