Trial Outcomes & Findings for EASI Access II --- Follow-up Study to the EASI Access Trial (NCT NCT00740727)

Results Overview

Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

1 day

Results posted on

2009-09-11

Participant Flow

Recruitment occurred in January 2009

A total of 20 subjects were consented. The study day ran long, so 2 subjects who had consented (and had an initial intravenous {IV} access placed, but no EASI access placed) declined to have any of the study procedures performed since the 2-hour phlebotomy window would have kept them at the study site until the evening.

Participant milestones

Participant milestones
Measure	EASI/HRH(Human Recombinant Hyaluronidase) Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EASI Access II --- Follow-up Study to the EASI Access Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EASI/HRH(Human Recombinant Hyaluronidase) n=18 Participants Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	25 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.

Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).

Outcome measures

Outcome measures
Measure	EASI/HRH(Human Recombinant Hyaluronidase) n=18 Participants Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Number of Participants With Successfully Placed EASI Lines	18 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.

Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.

Outcome measures

Outcome measures
Measure	EASI/HRH(Human Recombinant Hyaluronidase) n=18 Participants Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose	18 Participants

SECONDARY outcome

Timeframe: 1 day

Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.

Assessment during EASI placement \& initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.

Outcome measures

Outcome measures
Measure	EASI/HRH(Human Recombinant Hyaluronidase) n=18 Participants Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Number of Participants With Pain During EASI Infusion	2 Participants

SECONDARY outcome

Timeframe: 2 days

Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.

Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).

Outcome measures

Outcome measures
Measure	EASI/HRH(Human Recombinant Hyaluronidase) n=18 Participants Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up	0 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen H. Thomas MD MPH

Massachusetts General Hospital

Phone: 6177267622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place