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

NCT03070847 | Unknown Phase 4

• 1 other identifier: txa01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Reduction

Keywords

tranexamic acid; rhinoplasty; bleeding reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse effects

  during rhinoplasty and first day after surgery

• surgical field assesment

  during rhinoplasty

• surgery length

  during rhinoplasty

Study Arms (2)

Very low dose

EXPERIMENTAL

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; Drug: Sodium Chloride

Low dose

ACTIVE COMPARATOR

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; Drug: Sodium Chloride

Interventions

Tranexamic Acid DRUG

Dose: 5mg/kg

Also known as: Exacyl

Very low dose

Sodium Chloride DRUG

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

Low dose; Very low dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bartłomiej Wódarski: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie

Warsaw, Masovian Voivodeship, 00-416, Poland

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Bartłomiej Wódarski, MD

CONTACT

505064789; barwoda@gmail.com

Paweł Krzęczko, MD

CONTACT

pawkrze@o2.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 6, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)