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

Bartłomiej Wódarski

Status and phase: Unknown; Phase 4

Conditions: Bleeding Reduction

Treatments: Drug: Tranexamic Acid; Drug: Sodium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03070847

txa01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Very low dose

Experimental group

Description:

Will receive single bolus of Tranexamic acid. Dose: 5mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.

Treatment:

Drug: Sodium Chloride

Drug: Tranexamic Acid

Drug: Tranexamic Acid

Low dose

Active Comparator group

Description:

Will receive single bolus of Tranexamic acid. Dose: 10mg/kg diluted in 0,9% sodium chloride (0,9% NaCl), administered IV (in the vein), 15 min before admission to operation theatre.

Treatment:

Drug: Sodium Chloride

Drug: Tranexamic Acid

Drug: Tranexamic Acid