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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low dose | Experimental | 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. |
|
| Low dose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Dose: 5mg/kg |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bartłomiej Wódarski, MD | Contact | 505064789 | barwoda@gmail.com | |
| Paweł Krzęczko, MD | Contact | pawkrze@o2.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie | Recruiting | Warsaw | Masovian Voivodeship | 00-416 | Poland |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
| Tranexamic Acid | Drug | Dose: 10mg/kg |
|
|
| Sodium Chloride | Drug | Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml. |
|
| during rhinoplasty |
| surgery length | surgical procedure length would be noted | during rhinoplasty |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |