CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Human recombinant hyaluronidase (HRH) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00740727
NCT00740727Phase 1Completed
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Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial

Massachusetts General Hospital·interventional·Posted Aug 25, 2008·Updated Sep 11, 2009

In Brief

A Phase 1 clinical trial evaluating Human recombinant hyaluronidase (HRH) and Enzymatically Augmented Subcutaneous Infusion (EASI) line placement for Disaster Medicine and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisaster Medicine, Difficult Intravenous Access, Dehydration
CountriesUnited States
CollaboratorsBaxter Healthcare Corporation

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2008
Enrollment StartFeb 1, 2009
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.9 years ago

Interventions

Human recombinant hyaluronidase (HRH)drug

150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)

Enzymatically Augmented Subcutaneous Infusion (EASI) line placementprocedure

Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.