Status:
UNKNOWN
Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze
Lead Sponsor:
Sion Microtec Ltd.
Conditions:
Bleeding
Coagulopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Patients on chronic treatment with hemodialysis have an arterio-venous fistula which enable the insertion of two large gauge needles. At the end of dialysis the needles are extracted and continuous pr...
Detailed Description
A Double-blind safety and efficacy study comparing pad-gauze with tranexamic acid (Hemostopan™) to a regular pad-gauze in controlling bleeding in patients on hemodialysis. Background: Patients with ...
Eligibility Criteria
Inclusion
- Patients that require at least 10 minutes for hemostasis
- Patient over 18 years of age that are capable of signing an informed consent
Exclusion
- Patients with HIV, HCV or HBV chronic infection
- Known hypersensitivity to polydine
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01854476
Start Date
October 1 2013
End Date
August 1 2015
Last Update
February 13 2015
Active Locations (1)
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1
The dialysis unite at the Sheba Medical center
Ramat Gan, Israel, Israel, 52621