search
Back to results

Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery

Primary Purpose

Intraoperative Bleeding

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
Tranexamic Acid
Adrenalin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Bleeding

Eligibility Criteria

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

Inclusion Criteria:

  1. being candidate for ear exploration surgery.
  2. ASA I-II
  3. Willing to participate in the study
  4. Hb level > 10 mg/dl.
  5. normal coagulation profile (INR and PTT )

Exclusion Criteria:

  1. Patient refusal
  2. allergy toTXA
  3. Bleeding disorder
  4. psychiatric illness
  5. acute and chronic renal failure
  6. using heparin during 48 hr before surgery
  7. pregnancy
  8. cirrhosis
  9. colour blindness
  10. cardiac stent

Sites / Locations

  • EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Systemic TXA

Topical TXA

Topical adrenaline

Arm Description

TXA 10-15 mg i.v over 30 min. followed by infusion in a dose of 1 mg / kg /hr

Topical TXA 1 gm diluted in 200 ml saline

Topical adrenaline 1 mg diluted in 200 ml saline

Outcomes

Primary Outcome Measures

The quality of the surgical field
Boezaart grading with 0-5 scores.

Secondary Outcome Measures

intraoperative blood loss
Blood in the suction and the gauze

Full Information

First Posted
March 6, 2017
Last Updated
April 12, 2017
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03112135
Brief Title
Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery
Official Title
Effect of Topical and Systemic Tranexemic Acid on Bleeding and Quality of Surgical Field During Ear Exploration Surgery. A Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2017 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

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
No

5. Study Description

Brief Summary
The effect of tranexamic acid (TXA) on bleeding and improvement of surgical field during ear exploration surgery is not clear yet. This study will conducted to answer this question.
Detailed Description
Bleeding during ear surgery is still a challenge for surgeons and anesthesiologists . Although extensive blood loss is rare during ear surgery, however, establishing a favorite surgical field is often difficult. The reason is that even slight bleeding may distort the view of the field and increase the occurrence of complications, including deafness, the longer duration of surgery, or even inconclusive surgery . Many techniques have been proposed to improve the field of ear exploration surgery. Bipolar diathermy, packing, local vasoconstrictors, and induced hypotension are the most commonly used techniques . Diathermy can lead to local damage and delayed bleeding . Using topical vasoconstrictions can lead to hemodynamic instability especially in patients with a history of hypertension or ischemic heart disease. Induction hypotension exposes the patients to more anesthetic drugs and hence a higher risk of potential side effects. However, neither of these methods guarantees a desirable surgical field with no bleeding. Therefore, investigators are working on more effective and safer methods to reduce bleeding and hence to improve the field of surgery . Activation of fibrinolysis during and after surgery is a well-known phenomenon. Many mechanisms associated with coagulation disorders, such as surgical trauma, blood loss and consumption of coagulation factors and platelets, using crystalloid and colloid given during and after surgery, hypothermia, acidosis, foreign materials, and etc. In recent studies, systemic infusion of anti-fibrinolytic drugs have been used to reduce bleeding in various forms of surgery such as major orthopedic surgery,and adeno-tonsillectomy. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that binds to the lysine binding sites of plasmin and plasminogen. Saturation of the binding sites causes separation of plasminogen from superficial fibrin and hence prevents fibrinolysis. Any surgical procedure can cause a considerable tissue damage and hence trigger the release of enzymes, such as 'tissue plasminogen activator' that converts plasminogen to plasmin and activates fibrinolysis process. TXA can prevent fibrinolysis activity by inhibiting the activity of this enzyme. Systemic infusion of TXA associated with several potential side effects such as nausea, vomiting, diarrhea, allergic dermatitis, dizziness, hypotension, seizures, impaired vision, achromatopsia (impaired color vision), and particularly thromboembolic events. Several studies have been conducted on topical TXA in different types of surgery but no systemic absorption or side effects have been reported. To date, the effect of TXA on reduction of bleeding in ear surgery is unclear . There is no consensus on the efficacy of TXA and its effective dose in reducing bleeding. This trial will aim to assess the effect of topical TXA on bleeding and improvement of surgical field during ear surgery in patients with chronic ear disease.

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
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic TXA
Arm Type
Active Comparator
Arm Description
TXA 10-15 mg i.v over 30 min. followed by infusion in a dose of 1 mg / kg /hr
Arm Title
Topical TXA
Arm Type
Active Comparator
Arm Description
Topical TXA 1 gm diluted in 200 ml saline
Arm Title
Topical adrenaline
Arm Type
Active Comparator
Arm Description
Topical adrenaline 1 mg diluted in 200 ml saline
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
kapron
Intervention Description
TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
kapron
Intervention Description
Topical TXA 1 gm diluted in 200 ml saline
Intervention Type
Drug
Intervention Name(s)
Adrenalin
Other Intervention Name(s)
Epinephrine
Intervention Description
Topical adrenaline 1 mg diluted on 200 ml saline
Primary Outcome Measure Information:
Title
The quality of the surgical field
Description
Boezaart grading with 0-5 scores.
Time Frame
45 minutes after the start of surgery
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
Blood in the suction and the gauze
Time Frame
45 minutes after the start of surgery

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: being candidate for ear exploration surgery. ASA I-II Willing to participate in the study Hb level > 10 mg/dl. normal coagulation profile (INR and PTT ) Exclusion Criteria: Patient refusal allergy toTXA Bleeding disorder psychiatric illness acute and chronic renal failure using heparin during 48 hr before surgery pregnancy cirrhosis colour blindness cardiac stent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Ahmed, Dr
Phone
01068668302
Ext
088
Email
Sallyahmed720@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Ahmed, Dr
Organizational Affiliation
Assiut Univerisity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Egypt
City
Asyut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Ahmed, Dr
Phone
01068668302
Ext
088
Email
Sallyahmed720@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery

We'll reach out to this number within 24 hrs