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
About this trial
This is an interventional treatment trial for Intraoperative Bleeding
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
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
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
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Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery
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