Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04188184
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site: 30
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Bleeding	Drug: Tranexamic Acid; Drug: Epinephrine	N/A

Detailed Description

Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field during microscopic ear and sinus surgeries with controversial results given the possible cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding, discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of lysine amino acid; it acts reversibly on the lysine binding sites to block it on the plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively, thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and

1. More than 95% of TXA intravenous administered dose eliminated unchanged through the urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is minimally excreted in breast milk while it can freely cross the blood brain barrier and the placenta .

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy
• Actual Study Start Date: Dec 4, 2019
• Actual Primary Completion Date: Apr 10, 2020
• Actual Study Completion Date: Apr 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tranexmic acid 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; 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.
Active Comparator: Epinephrine roup 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; 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.

Outcome Measures

Primary Outcome Measures

1. State of surgical field categorized by surgeons based on Boezaart classification [2 hour]

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

Secondary Outcome Measures

1. bleeding volume [2 hour]

   The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 - 60 years old

• ASA (I and II)

• Hb level > 10 mg/dl

• elective ear exploratory tympanotomy surgery under general anesthesia.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71111
2	Faculty of Medicine	Asyut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rasha Hamed, Director, Assiut University
• ClinicalTrials.gov Identifier: NCT04188184
• Other Study ID Numbers: 17300198
• First Posted: Dec 5, 2019
• Last Update Posted: Apr 21, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Blood Loss, Surgical; Epinephrine; Tranexamic Acid

Study Results

No Results Posted as of Apr 21, 2020