NCT00927381

Brief Summary

Retrospective observational review of severe envenomation treatment with CroFab

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

Same day

First QC Date

June 23, 2009

Last Update Submit

June 22, 2022

Conditions

Snake Envenomation

Outcome Measures

Primary Outcomes (1)

  • Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.

    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.

    following treatment

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients bitten by a pit viper and treated with CroFab between January 1, 2002 and December 31 2004.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Poison and Drug Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Richard C Dart, MD, PhD

    Rocky Mountain Poison and Drug Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

January 1, 2005

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

June 28, 2022

Record last verified: 2022-06

Locations

US(1)