Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy

Intraoperative Bleeding Clinical Trial

Official title:

Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188184
• Other study ID #: 17300198
• Status: Completed
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: April 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 VIII. 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut
Egypt	Faculty of Medicine	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State of surgical field categorized by surgeons based on Boezaart classification	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	2 hour
Secondary	bleeding volume	The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.	2 hour