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Recombinant Hyaluronidase in Out-of-Hospital Setting: The EASI Access Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00386386
First Posted: October 11, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Massachusetts General Hospital
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enzymatically Augmented Subcutaneous Infusion (EASI) In Out-Of-Hospital Care

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Ability to achieve hydration with subcutaneous infusion
  • Ability to get subcutaneously administered glucose into the vascular compartment
  • Safety of subcutaneous infusion
  • Rapidity of subcutaneous infusion as compared to standard IV infusion

Secondary Outcome Measures:
  • Pain associated with subcutaneous infusion vs. IV infusion

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults participating in disaster medicine drill

Exclusion Criteria:

  • Diabetes
  • Allergy to hyaluronidase or its components
  • High doses of estrogens
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386386


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Baxter Healthcare Corporation
Investigators
Principal Investigator: Stephen H Thomas, MD MPH Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen THomas, MGH
ClinicalTrials.gov Identifier: NCT00386386     History of Changes
Other Study ID Numbers: Hylenex1
First Submitted: October 6, 2006
First Posted: October 11, 2006
Last Update Posted: October 12, 2017
Last Verified: March 2008

Keywords provided by Massachusetts General Hospital:
hydration
prehospital
mass casualty incident

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes