Snake EnvenomationNCT00927381
Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation
An observational study of Snake Envenomation, run by BTG International Inc. at 1 site in United States.
Trial summary
Retrospective observational review of severe envenomation treatment with CroFab Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snake Envenomation
- How many people
- 247 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients bitten by a pit viper and treated with CroFab between January 1, 2002 and December 31 2004.
Who may be able to join
- 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.
Who cannot join
- Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Poison and Drug Center
Denver, Colorado, 80204
About this study
Official title: 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
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.
- Conditions
- Snake Envenomation
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.
Measured: 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.
Measured: following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTG International Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard C Dart, MD, PhD, Principal investigator, Rocky Mountain Poison and Drug Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927381
- Sponsor's protocol ID
- MC03/03/05
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2009
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations
- ClinicalTrials.gov ID
- NCT00927381
- Acronym / sponsor ID
- MC03/03/05
- Conditions
- Snake Envenomation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- BTG International Inc.University, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective observational review of severe envenomation treatment with CroFab
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients bitten by a pit viper and treated with CroFab between January 1, 2002 and December 31 2004.
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Dart, MD, PhD principal investigator
Rocky Mountain Poison and Drug Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snake Envenomation, run by BTG International Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.