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

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

Sponsors

Lead sponsor: Bartłomiej Wódarski

Source Centre of Postgraduate Medical Education
Brief 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).

Overall Status Unknown status
Start Date March 1, 2017
Completion Date March 2019
Primary Completion Date March 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Intraoperational bleeding during rhinoplasty
Secondary Outcome
Measure Time Frame
Adverse effects during rhinoplasty and first day after surgery
surgical field assesment during rhinoplasty
surgery length during rhinoplasty
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: Tranexamic Acid

Description: Dose: 5mg/kg

Arm group label: Very low dose

Other name: Exacyl

Intervention type: Drug

Intervention name: Tranexamic Acid

Description: Dose: 10mg/kg

Arm group label: Low dose

Other name: Exacyl

Intervention type: Drug

Intervention name: Sodium Chloride

Description: Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Bartłomiej Wódarski, MD

Phone: 505064789

Email: [email protected]

Location
facility status contact contact_backup investigator Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie Bartłomiej Wódarski, MD 505064789 [email protected] Paweł Krzęczko, MD Principal Investigator Kamil Radzikowski, MD Sub-Investigator Małgorzata Malec-Milewska, MD, PhD Sub-Investigator
Location Countries

Poland

Verification Date

August 2017

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Centre of Postgraduate Medical Education

Investigator full name: Bartłomiej Wódarski

Investigator title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Very low dose

Arm group type: Experimental

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.

Arm group label: Low dose

Arm group type: Active Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Triple (Participant, Care Provider, Investigator)

Masking description: Blinded (participant, care provider, investigator). Computer block randomisation tool will be used (randomisation.com 1 block, 50 subjects per block), 50 notes with '5 mg/kg' or '10 mg/kg' will be put into sealed envelopes.

Source: ClinicalTrials.gov