Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

June 22, 2022 updated by: BTG International Inc.

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

Retrospective observational review of severe envenomation treatment with CroFab

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Rocky Mountain Poison and Drug Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at baseline and following treatment with CroFab

Secondary Outcome Measures

Outcome Measure
Time Frame
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
following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTG International Inc.

Investigators

  • Principal Investigator: Richard C Dart, MD, PhD, Rocky Mountain Poison and Drug Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

June 23, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimate)

June 25, 2009

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC03/03/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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