Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00927381
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 25, 2009
Information provided by:
BTG International Inc.

Brief Summary:
Retrospective observational review of severe envenomation treatment with CroFab

Condition or disease
Snake Envenomation

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 with a mild/moderate envenomation.

Study Type : Observational
Actual Enrollment : 247 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations
Study Start Date : January 2005
Actual Study Completion Date : December 2005

Severe envenomation
Patients with a calculated severity score of 5 or 6 were included in this group.
Minimal/Moderate Envenomation
Severity Score less than 5

Primary Outcome Measures :
  1. Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points. [ Time Frame: at baseline and following treatment with CroFab ]

Secondary Outcome Measures :
  1. The presence of venom effects, comparison of venom effects over time, initial control of venom effects, recurrence of venom effects, and delayed onset of venom effects. [ Time Frame: following treatment ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients bitten by a pit viper and treated with CroFab between January 1, 2002 and December 31 2004.

Inclusion Criteria:

  • 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:

    1. Clinical signs/symptoms prior to the first dose of antivenom,
    2. Documentation of ALL doses of antivenom used to treat the patient,
    3. 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 Criteria:

  • Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00927381

United States, Colorado
Rocky Mountain Poison and Drug Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
BTG International Inc.
Principal Investigator: Richard C Dart, MD, PhD Rocky Mountain Poison and Drug Center

Responsible Party: Protherics Identifier: NCT00927381     History of Changes
Other Study ID Numbers: MC03/03/05
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Snake Bites
Chemically-Induced Disorders
Bites and Stings
Wounds and Injuries