A Phase 4 interventional study of Tranexamic Acid and Tranexamic Acid in Bleeding Reduction, sponsored by Bartłomiej Wódarski. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Bartłomiej Wódarski · Phase 4, Interventional, and Supportive care
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.
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).
Bartłomiej Wódarski is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
Dose: 5mg/kg
Also known as: Exacyl
Dose: 10mg/kg
Also known as: Exacyl
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
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)
Time frame: during rhinoplasty
Adverse effects
any adverse effects connected with tranexamic acid usage would be noted
Time frame: during rhinoplasty and first day after surgery
surgical field assesment
Fromm scale of surgical field would be used
Time frame: during rhinoplasty
surgery length
surgical procedure length would be noted
Time frame: during rhinoplasty
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid
Bartłomiej Wódarski