Low vs. Very Low Dose of Prophylactic Tranexamic Acid for Bleeding Reduction During Rhinoplasty
NCT ID: NCT03070847
Last Updated: 2017-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2017-03-01
2019-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
Tranexamic Acid
Dose: 5mg/kg
Sodium Chloride
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
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.
Tranexamic Acid
Dose: 10mg/kg
Sodium Chloride
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
Interventions
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Tranexamic Acid
Dose: 5mg/kg
Tranexamic Acid
Dose: 10mg/kg
Sodium Chloride
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Bartłomiej Wódarski
OTHER
Responsible Party
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Bartłomiej Wódarski
MD
Locations
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Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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txa01
Identifier Type: -
Identifier Source: org_study_id
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