Bleeding Reduction
Conditions
Keywords
tranexamic acid, rhinoplasty, bleeding reduction
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.
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).
Interventions
DRUGTranexamic Acid
Dose: 5mg/kg
DRUGSodium Chloride
Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
Sponsors
Bartłomiej Wódarski
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperational bleeding | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | during rhinoplasty and first day after surgery | any adverse effects connected with tranexamic acid usage would be noted |
| surgical field assesment | during rhinoplasty | Fromm scale of surgical field would be used |
| surgery length | during rhinoplasty | surgical procedure length would be noted |
Countries
Poland
Contacts
Primary ContactBartłomiej Wódarski, MD
Backup ContactPaweł Krzęczko, MD
Outcome results
None listed