Bleeding Reduction Clinical Trial
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
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03326323 -
Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
|