Status:
COMPLETED
EASI Access II --- Follow-up Study to the EASI Access Trial
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Disaster Medicine
Difficult Intravenous Access
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absor...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects will be at least 18 years of age and have none of the following conditions:
- pregnancy (negative urine pregnancy test to be performed before study participation),
- diabetes, or coagulopathic (including taking any anticoagulants);
- Subjects cannot be taking steroids or other immunosuppressants.
- Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations.
- Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00740727
Start Date
February 1 2009
End Date
March 1 2009
Last Update
September 11 2009
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114