Status:
COMPLETED
Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation
Lead Sponsor:
BTG International Inc.
Conditions:
Snake Envenomation
Eligibility:
All Genders
Brief Summary
Retrospective observational review of severe envenomation treatment with CroFab
Detailed Description
The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those wit...
Eligibility Criteria
Inclusion
- Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004
- The record must contain all of the following:
- Clinical signs/symptoms prior to the first dose of antivenom,
- Documentation of all doses of antivenom used to treat the patient,
- Indication of whether or not initial control was achieved with antivenom.
- To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria:
- Must contain enough information to calculate a severity score based on the 7-point severity scale.
- All records were included in the Safety Population in the current analysis.
Exclusion
- Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00927381
Start Date
January 1 2005
End Date
January 1 2005
Last Update
June 28 2022
Active Locations (1)
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1
Rocky Mountain Poison and Drug Center
Denver, Colorado, United States, 80204