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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Bleeding

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 3, 2019
Last Updated
April 17, 2020
Sponsor
Assiut University
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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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