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Completed

NCT Number: NCT00927381

Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

Retrospective observational review of severe envenomation treatment with CroFab

Completed

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Key information

Conditions

Snake Envenomation Bites and Stings Chemically-Induced Disorders Poisoning Snake Bites Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocky Mountain Poison and Drug Center

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BTG International Inc.

Other

Registry information

Official study title

Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jun 25, 2009
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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