Effect of Topical and Systemic Tranexemic Acid on Bleeding During Ear Exploration Surgery
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedApril 13, 2017
April 1, 2017
9 months
March 6, 2017
April 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The quality of the surgical field
Boezaart grading with 0-5 scores.
45 minutes after the start of surgery
Secondary Outcomes (1)
intraoperative blood loss
45 minutes after the start of surgery
Study Arms (3)
Systemic TXA
ACTIVE COMPARATORTXA 10-15 mg i.v over 30 min. followed by infusion in a dose of 1 mg / kg /hr
Topical TXA
ACTIVE COMPARATORTopical TXA 1 gm diluted in 200 ml saline
Topical adrenaline
ACTIVE COMPARATORTopical adrenaline 1 mg diluted in 200 ml saline
Interventions
TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr
Topical adrenaline 1 mg diluted on 200 ml saline
Eligibility Criteria
You may qualify if:
- 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 )
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Egypt
Asyut, Asyut Governorate, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sally Ahmed, Dr
Assiut Univerisity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2017
First Posted
April 13, 2017
Study Start
April 1, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
April 13, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share