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CompletedNCT00927381Updated Jun 28, 2022

Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

An observational study in Snake Envenomation, sponsored by BTG International Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by BTG International Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
247
Sex
All
01

Study summary

Retrospective observational review of severe envenomation treatment with CroFab

Read the 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.

02

Conditions studied

  • Snake Envenomation

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03

In context

Snake Bites

38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.

This study's enrollment of 247 is above the median of 99 across 19 observational studies indexed under Snake Bites.

Browse Snake Bites studies →

Lead sponsor

BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
247 participants (actual)

Groups and 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

06

What researchers measure

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

07

Study locations

1 site
  • Rocky Mountain Poison and Drug Center
    Denver, Colorado 80204, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Jan 2005 and a completion of Jan 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2009
First posted
Jun 25, 2009
Start
Jan 2005
Primary completionActual
Jan 2005
CompletionActual
Jan 2005
Last update
Jun 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00927381
Lead sponsor
BTG International Inc.
Responsible party
Sponsor
First posted
Jun 25, 2009
Start date
Jan 2005
Primary completion
Jan 2005
Completion
Jan 2005
Last update
Jun 28, 2022

Study contacts

Richard C Dart, MD, PhD
principal investigator · Rocky Mountain Poison and Drug Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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BTG International Inc.

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