Nebulized Tranexamic Acid in Sinus Surgery

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Bleeding Nose

Treatments: Drug: Tranexamic acid; Other: Saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04905901

17300595

Details and patient eligibility

About

The results of several recent studies on endoscopic sinus surgery through topical administration of tranexamic acid are encouraging in terms of the efficacy of tranexamic acid for intraoperative bleeding and other pathological conditions.The purpose of this study is to analyze the efficacy of nebulized tranexamic acid to improve the surgeon and patient experiences of sinus surgery and know the effective and safe dose of nebulized tranexamic acid.

Full description

A written informed consent will be taken from the patients.The study involved adults of either sexes (age 18-65 years) of ASA I-II who will be listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia, with normal accepted coagulation profile and hematocrit value ≥30 %. Excluded from the study patients with chronic renal failure, liver cirrhosis, bleeding disorders, current anticoagulant therapy, pregnancy or breastfeeding, impaired color vision, severe vascular ischemia, history of venous thrombosis, pulmonary embolism, long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery, a hemoglobin (HB) concentration <10 mg/dl or allergy to TXA.

Randomization: A random number sequence created by an internet website (http://www. random.org) will be used for patients' allocation. The random number sequence was retained in closed opaque envelopes released the day of the surgery by an independent physician not involved in the study. Patients will be assigned randomly to three groups (30 subjects each); saline placebo (Group S) and two different doses of preemptive nebulized tranexamic acid (Group T1) and (Group T2).To keep blinding, Group S will receive 2 sessions of nebulization each by 5 ml saline. Group T1 will receive one nebulization session 500 mg tranexamic acid (5 ml) and another one by 5 ml saline. Group T2 will receive 2 nebulization sessions each by 500 mg tranexamic acid (each by 5 ml)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Either sexes (age 18-65 years) of ASA I-II who are listed for elective functional endoscopic sinus surgery (FESS) under general anesthesia
• normal accepted coagulation profile and hematocrit value ≥30

Exclusion criteria

• chronic renal failure
• liver cirrhosis
• bleeding disorders
• current anticoagulant therapy
• pregnancy or breastfeeding
• impaired color vision
• severe vascular ischemia
• history of venous thrombosis, pulmonary embolism
• long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before surgery
• hemoglobin (HB) concentration <10 mg/dl _allergy to TXA.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 3 patient groups, including a placebo group

Tranexamic acid 500 mg

Experimental group

Description:

Nebulized tranexamic acid 500 mg 15 minutes before operation

Treatment:

Drug: Tranexamic acid

Tranexamic acid 1gm

Experimental group

Description:

Nebulized tranexamic acid 1 gm 15 minutes before operation

Treatment:

Drug: Tranexamic acid

Saline placebo

Placebo Comparator group

Description:

Normal saline nebulization 15 minutes before operation

Treatment:

Other: Saline placebo