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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Bleeding Reduction

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Tranexamic Acid
* Drug: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very low dose<br>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<br>* Dose: 5mg/kg<br>* Other names: Exacyl;Drug: Sodium Chloride<br>* Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.<br>|
| Active Comparator: Low dose<br>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<br>* Dose: 10mg/kg<br>* Other names: Exacyl;Drug: Sodium Chloride<br>* Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | during rhinoplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | any adverse effects connected with tranexamic acid usage would be noted | during rhinoplasty and first day after surgery | 
| surgical field assesment | Fromm scale of surgical field would be used | during rhinoplasty | 
| surgery length | surgical procedure length would be noted | during rhinoplasty | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, rhinoplasty, bleeding reduction