Clinical trial NCT03070847: Low vs. Very Low Dose of Prophylactic Tranexamic Acid for Bleeding Reduction During Rhinoplasty
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bleeding Reduction
Keywords: tranexamic acid
rhinoplasty
bleeding reduction
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Intraoperational bleeding
timeFrame: during rhinoplasty
Secondary outcomes:
measure: Adverse effects
timeFrame: during rhinoplasty and first day after surgery
measure: surgical field assesment
timeFrame: during rhinoplasty
measure: surgery length
timeFrame: during rhinoplasty
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie
state: Mazowieckie
Study officials:
References: