- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188184
Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
April 17, 2020 updated by: Rasha Hamed, Assiut University
Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71111
- Assiut University
-
Asyut, Egypt, 71111
- Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State of surgical field categorized by surgeons based on Boezaart classification
Time Frame: 2 hour
|
Grade Description 0 No bleeding (cadaveric conditions)
|
2 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding volume
Time Frame: 2 hour
|
The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.
|
2 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 4, 2019
Primary Completion (ACTUAL)
April 10, 2020
Study Completion (ACTUAL)
April 10, 2020
Study Registration Dates
First Submitted
December 3, 2019
First Submitted That Met QC Criteria
December 4, 2019
First Posted (ACTUAL)
December 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Hemorrhage
- Intraoperative Complications
- Blood Loss, Surgical
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Fibrin Modulating Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Tranexamic Acid
- Epinephrine
Other Study ID Numbers
- 17300198
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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