Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation
This study has been completed.
Sponsor:
Protherics
Information provided by:
Protherics
ClinicalTrials.gov Identifier:
NCT00927381
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
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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 Protherics:
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:
- 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.
Contacts and Locations
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
Protherics
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 May 19, 2013