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

NCT00386386 | Completed Phase 3

• 1 other identifier: Hylenex1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mass Casualty Incident; Dehydration

Keywords

hydration; prehospital; mass casualty incident

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Pain associated with subcutaneous infusion vs. IV infusion

Study Arms (1)

1

OTHER

Subject receives two infusions: One by EASI Access and one by IV access, at different sites

Other: hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion

Interventions

hypodermoclysis via recombinant hyaluronidase-facilitated subcutaneous infusion OTHER

Above

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults participating in disaster medicine drill

You may not qualify if:

• Diabetes
• Allergy to hyaluronidase or its components
• High doses of estrogens

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Soremekun OA, Shear ML, Patel S, Kim GJ, Biddinger PD, Parry BA, Yialamas MA, Thomas SH. Rapid vascular glucose uptake via enzyme-assisted subcutaneous infusion: enzyme-assisted subcutaneous infusion access study. Am J Emerg Med. 2009 Nov;27(9):1072-80. doi: 10.1016/j.ajem.2008.08.028.

  PMID: 19931753 DERIVED

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen H Thomas, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

US (1)