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

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ClinicalTrials.gov Identifier: NCT03070847
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Bartłomiej Wódarski, 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.

Condition or disease Intervention/treatment Phase
Bleeding Reduction Drug: Tranexamic Acid Drug: Sodium Chloride Phase 4

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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: 10mg/kg
Other Name: Exacyl

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




Primary Outcome Measures :
  1. Intraoperational bleeding [ Time Frame: during rhinoplasty ]
    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)


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: during rhinoplasty and first day after surgery ]
    any adverse effects connected with tranexamic acid usage would be noted

  2. surgical field assesment [ Time Frame: during rhinoplasty ]
    Fromm scale of surgical field would be used

  3. surgery length [ Time Frame: during rhinoplasty ]
    surgical procedure length would be noted



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070847


Contacts
Contact: Bartłomiej Wódarski, MD 505064789 barwoda@gmail.com
Contact: Paweł Krzęczko, MD pawkrze@o2.pl

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

Responsible Party: Bartłomiej Wódarski, MD, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT03070847     History of Changes
Other Study ID Numbers: txa01
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Bartłomiej Wódarski, Centre of Postgraduate Medical Education:
tranexamic acid
rhinoplasty
bleeding reduction

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants