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

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)

  1. Slight bleeding: no suctioning required
  2. Slight bleeding: occasional suctioning required
  3. Slight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed
  4. Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed
  5. 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 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.

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

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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