Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

This study has been completed.
Sponsor:
Information provided by:
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT00927381
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

Retrospective observational review of severe envenomation treatment with CroFab


Condition
Snake Envenomation

Study Type: Observational
Study Design: 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

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 247
Study Start Date: January 2005
Study Completion Date: December 2005
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927381

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

No publications provided

Responsible Party: Protherics
ClinicalTrials.gov Identifier: NCT00927381     History of Changes
Other Study ID Numbers: MC03/03/05
Study First Received: June 23, 2009
Last Updated: June 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 24, 2014