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

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.

Study Overview

• Status: Unknown
• Conditions: Bleeding Reduction
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Tranexamic Acid; Drug: Sodium Chloride

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).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bartłomiej Wódarski, MD; Phone Number: 505064789; Email: barwoda@gmail.com
• Study Contact Backup: Name: Paweł Krzęczko, MD; Email: pawkrze@o2.pl

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 00-416
      • Recruiting
      • Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie
      • Contact: Bartłomiej Wódarski, MD; Phone Number: 505064789; Email: barwoda@gmail.com
      • Contact: Paweł Krzęczko, MD; Email: pawkrze@o2.pl
      • Principal Investigator: Paweł Krzęczko, MD
      • Sub-Investigator: Kamil Radzikowski, MD
      • Sub-Investigator: Małgorzata Malec-Milewska, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Very low dose; 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.	Drug: Tranexamic Acid; Dose: 5mg/kg; Other Names: Exacyl; Drug: Tranexamic Acid; Dose: 10mg/kg; Other Names: Exacyl; Drug: Sodium Chloride; Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
ACTIVE_COMPARATOR: Low dose; 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.	Drug: Tranexamic Acid; Dose: 5mg/kg; Other Names: Exacyl; Drug: Tranexamic Acid; Dose: 10mg/kg; Other Names: Exacyl; Drug: Sodium Chloride; Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	any adverse effects connected with tranexamic acid usage would be noted	during rhinoplasty and first day after surgery
surgical field assesment	Fromm scale of surgical field would be used	during rhinoplasty
surgery length	surgical procedure length would be noted	during rhinoplasty

Collaborators and Investigators

• Sponsor: Bartłomiej Wódarski

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: tranexamic acid; rhinoplasty; bleeding reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No