Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04188184
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2019-12-03
Brief Title:
Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 absorptionespecially in vulnerable cardiac patientsTranexamic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None