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

Bleeding Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070847
• Other study ID #: txa01
• Status: Recruiting
• Phase: Phase 4
• First received: February 21, 2017
• Last updated: August 28, 2017
• Start date: March 1, 2017
• Est. completion date: March 2019

Study information

• Verified date: August 2017
• Source: Centre of Postgraduate Medical Education
• Contact: Bartlomiej Wódarski, MD
• Phone: 505064789
• Email: barwoda[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age > 18 y.o.

• American Society of Anesthesiologists Physical Status Classification (ASA) 1-2

• signed informed consent form after reading the information about the study and talking with one of the investigators

Exclusion Criteria:

• pregnancy

• known allergies for tranexamic acid or any other substance in Exacyl

• deep vein thrombosis

• Hormone Replacement Therapy or oral contraceptive usage

• anticoagulants usage

• obesity - BMI (body mass index) >30 kg/m2

• renal disease, as glomerular filtration rate (GFR) <60 ml/min/1,73 m*m

• seizures or epilepsy in the past

Related Conditions & MeSH terms

• Bleeding Reduction
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orlowskiego w Warszawie	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Bartlomiej Wódarski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperational bleeding	it would be assessed at the end of the surgery by measuring blood volume in the suction device and net weight of all surgical material. (precision balance - 2 mg)	during rhinoplasty
Secondary	Adverse effects	any adverse effects connected with tranexamic acid usage would be noted	during rhinoplasty and first day after surgery
Secondary	surgical field assesment	Fromm scale of surgical field would be used	during rhinoplasty
Secondary	surgery length	surgical procedure length would be noted	during rhinoplasty