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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00740727
First received: August 21, 2008
Last updated: September 10, 2009
Last verified: September 2009
History of Changes
Results First Received: March 3, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Disaster Medicine
Difficult Intravenous Access
Dehydration
Interventions: Drug: Human recombinant hyaluronidase (HRH)
Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred in January 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
EASI/HRH(Human Recombinant Hyaluronidase) Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters

Participant Flow:   Overall Study
    EASI/HRH(Human Recombinant Hyaluronidase)  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
EASI/HRH(Human Recombinant Hyaluronidase) Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters

Baseline Measures
    EASI/HRH(Human Recombinant Hyaluronidase)  
Number of Participants  
[units: participants]
 		  18  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25  ± 7  
Gender  
[units: participants]
 		 
Female     3  
Male     15  
Region of Enrollment  
[units: participants]
 		 
United States     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Successfully Placed EASI Lines   [ Time Frame: 1 day ]
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Measure Type Primary
Measure Title Number of Participants With Successfully Placed EASI Lines
Measure Description

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).
Time Frame 1 day  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.

Reporting Groups
  Description
EASI/HRH(Human Recombinant Hyaluronidase) Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters

Measured Values
    EASI/HRH(Human Recombinant Hyaluronidase)  
Number of Participants Analyzed  
[units: participants]
 		  18  
Number of Participants With Successfully Placed EASI Lines  
[units: Participants]
 		  18  

No statistical analysis provided for Number of Participants With Successfully Placed EASI Lines



2.  Primary:   Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose   [ Time Frame: 1 day ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Pain During EASI Infusion   [ Time Frame: 1 day ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up   [ Time Frame: 2 days ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Stephen H. Thomas MD MPH
Organization: Massachusetts General Hospital
phone: 6177267622
e-mail: stephen-thomas@ouhsc.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: Stephen H. Thomas MD MPH, Massachusetts General Hospital/Harvard Medical School
ClinicalTrials.gov Identifier: NCT00740727     History of Changes
Other Study ID Numbers: EASI Access II
Study First Received: August 21, 2008
Results First Received: March 3, 2009
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board