Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
Primary Purpose
Intraoperative Bleeding
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
Epinephrine
Sponsored by
About this trial
This is an interventional prevention trial for Intraoperative Bleeding
Eligibility Criteria
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.
Sites / Locations
- Assiut university
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tranexmic acid
Epinephrine roup
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
bleeding volume
The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04188184
Brief Title
Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
Official Title
Topical Use of Tranexamic Acid Versus Epinephrine to Optimize Surgical Field During Exploratory Tympanotomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexmic acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Epinephrine roup
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
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.
Primary Outcome Measure Information:
Title
State of surgical field categorized by surgeons based on Boezaart classification
Description
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
Time Frame
2 hour
Secondary Outcome Measure Information:
Title
bleeding volume
Description
The quantity of blood (ml) = (mass of used + fresh gauze - weight of all sponges before surgery) / 1.05.
Time Frame
2 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Name
Faculty of Medicine
City
Asyut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
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Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
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