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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00386386
First received: October 6, 2006
Last updated: March 12, 2008
Last verified: March 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Massachusetts General Hospital

Additional 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
Study First Received: October 6, 2006
Last Updated: March 12, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 15, 2014