Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

NCT04188184 | Completed DMC

• 1 other identifier: 17300198
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and management of unexplained conductive hearing loss, performed under an oto-microscope across the external auditory canal after tympanic membrane elevation to explore the middle ear structures

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• State of surgical field categorized by surgeons based on Boezaart classification

  Grade Description 0 No bleeding (cadaveric conditions) 1. Slight bleeding: no suctioning required 2. Slight bleeding: occasional suctioning required 3. Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed 4. Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed 5. Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible

  2 hour

Secondary Outcomes (1)

• bleeding volume

  2 hour

Study Arms (2)

tranexmic acid

ACTIVE COMPARATOR

received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Drug: Tranexamic Acid

Epinephrine roup

ACTIVE COMPARATOR

received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Drug: Epinephrine

Interventions

Tranexamic Acid DRUG

received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

tranexmic acid

Epinephrine DRUG

received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.

Epinephrine roup

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• ASA (I and II)
• Hb level \> 10 mg/dl
• elective ear exploratory tympanotomy surgery under general anesthesia.

You may not qualify if:

• Allergy to TXA
• bleeding/coagulation disorders
• psychiatric illness
• acute and chronic renal failure
• heparin use within 48 hrs or aspirin use within seven days before surgery,
• pregnancy
• liver cirrhosis
• color blindness
• cardiac stent.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university

Asyut, 71111, Egypt

Location

Faculty of Medicine

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic Acid; Epinephrine

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 4, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

EG (2)