Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Massachusetts General Hospital Baxter Healthcare Corporation |
---|---|
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00386386 |
The study's overarching aim is to determine whether Enzymatically Augmented Subcutaneous Infusion (EASI) can assist in out-of-hospital situations characterized by mismatch between need for, and ability to achieve, access to the vascular compartment. One mechanism for providing access to the vascular compartment, subcutaneous infusion, is facilitated by administration of hyaluronidase; the hyaluronidase hydrolyzes hyaluronan the major subcutaneous diffusion barrier. Hyaluronidase thus increases local dispersion and absorption of subcutaneously administered drugs and fluids.
The EASI Access study is intended to be the first out-of-hospital study assessing FDA-approved Chinese hamster ovary-derived recombinant hyaluronidase (the recombinant product is hereafter referred to by the shorter brand name, Hylenex). The EASI Access will test some fundamental principles and will facilitate design and implementation of follow-up investigations (e.g. extension of access to non-ALS providers). For example, we will attempt to show that EASI access is simple, effective, and has few or no downsides as compared to IV access.
Condition | Intervention | Phase |
---|---|---|
Mass Casualty Incident Dehydration |
Other: hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Enzymatically Augmented Subcutaneous Infusion (EASI) In Out-Of-Hospital Care |
Enrollment: | 20 |
Study Start Date: | May 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Subject receives two infusions: One by EASI Access and one by IV access, at different sites
|
Other: hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion
Above
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Stephen H Thomas, MD MPH | Massachusetts General Hospital |
Responsible Party: | MGH ( Stephen THomas ) |
Study ID Numbers: | Hylenex1 |
Study First Received: | October 6, 2006 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00386386 |
Health Authority: | United States: Institutional Review Board |
hydration prehospital mass casualty incident |
Metabolic Diseases Water-Electrolyte Imbalance Metabolic disorder Dehydration |
Pathologic Processes |