Snake BitesNCT04470791
Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.
A study testing F(ab)2 antivenom therapy (antivipmyn®). and Local cryotherapy. in people with Snake Bites, run by Hospital Juarez de Mexico.
Trial summary
The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Snake Bites
- What is being tested?
- F(ab)2 antivenom therapy (antivipmyn®). and Local cryotherapy.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jul 2017
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders and any age with a snake bite of poison grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
Who cannot join
- Patients of both genders and any age with a snake bite of poison grade I, III or IV who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
About this study
Official title: Cryotherapy as a Coadjuvant in the Management of Crotaline Snakebite With F(ab')2 Antivenom: A Randomized Pilot Study.
The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.
Read the detailed description
Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite treatment with F(ab')2 antivenom is unknown.
Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom.
Material and methods: Subjects with snakebite envenomation accident grade II, according to the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom therapy.
- Conditions
- Snake Bites
- Being tested
- F(ab)2 antivenom therapy (antivipmyn®)., Local cryotherapy.
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F(ab)2 antivenom therapy (antivipmyn®).Biological
Antivipmyn is an equine origin antivenom produced by Institute Bioclon in Mexico (Silanes Laboratories, México). The snake venoms used to create the F(ab')2 fragments are from Crotalus durissus and Bothrops asper. The number of doses of each patient depended on the classification and evolution, as indicated by the manufacturer for grade II envenoming: from 6 to 10 bottles of F(ab)2 antivenom therapy, intravenously, as an initial dose. One dose (bottle) consisted of 10 mL of polyvalent concentrated and modified horse antibodies treated by enzymatic digestion to neutralize the Bothrops asper venom to not less than 780 lethal dose 50 (LD50), and the Crotalus basiliscus venom to not less than 790 LD50.
Local cryotherapy.Procedure or surgery
Interval cryotherapy consisted of applying a plastic bag (the size of the bag depending on the size of the lesion, approximately 28 x 46 cm) two-thirds filled with crushed ice (frapped) wrapped in a towel applied for 20 minutes every 4 hours at the site of the snakebite throughout the hospital stay. New ice bags were used after 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| F(ab')2 antivenom plus local cryotherapy. | Experimental | Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy. Receives: Biological: F(ab)2 antivenom therapy (antivipmyn®).; Procedure: Local cryotherapy. |
| F(ab')2 antivenom. | Active comparator | Group B: patients who received only F(ab')2 antivenom therapy. Receives: Biological: F(ab)2 antivenom therapy (antivipmyn®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity.
Measured: Baseline.
Proximal circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity.
Measured: Baseline.
Middle circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity.
Measured: Baseline.
Distal circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
Measured: up to 24 weeks
Proximal circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
Measured: up to 24 weeks.
Middle circumference of the affected limb on hospital admission.
The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
Measured: up to 24 weeks.
Secondary outcomes (1)
Hospital stay.
The length of an inpatient episode of care, calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital. Patients admitted and discharged on the same day have a length of stay of less than one day.
Measured: up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jan 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake BitesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized pilot study was performed that included patients of both genders and over 18 years old with a snakebite of envenomation grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mario Adan Moreno Eutimio, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470791
- Sponsor's protocol ID
- HJM 0142/16-R
- Other IDs
- HJM 0142/16-R
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy as a Coadjuvant in the Management of Crotaline Snakebite With F(ab')2 Antivenom: A Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT04470791
- Acronym / sponsor ID
- HJM 0142/16-R
- Conditions
- Snake Bites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.
Detailed description
Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite treatment with F(ab')2 antivenom is unknown.
Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom.
Material and methods: Subjects with snakebite envenomation accident grade II, according to the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized pilot study was performed that included patients of both genders and over 18 years old with a snakebite of envenomation grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
| Arm | Type | Receives |
|---|---|---|
| F(ab')2 antivenom plus local cryotherapy. | Experimental | Biological: F(ab)2 antivenom therapy (antivipmyn®)., Procedure: Local cryotherapy.Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy. |
| F(ab')2 antivenom. | Active comparator | Biological: F(ab)2 antivenom therapy (antivipmyn®).Group B: patients who received only F(ab')2 antivenom therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of both genders and any age with a snake bite of poison grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
Key exclusion criteria (1 listed)
- Patients of both genders and any age with a snake bite of poison grade I, III or IV who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F(ab)2 antivenom therapy (antivipmyn®).Antivipmyn is an equine origin antivenom produced by Institute Bioclon in Mexico (Silanes Laboratories, México). The snake venoms used to create the F(ab')2 fragments are from Crotalus durissus and Bothrops asper. The number of doses of each patient depended on the classification and evolution, as indicated by the manufacturer for grade II envenoming: from 6 to 10 bottles of F(ab)2 antivenom therapy, intravenously, as an initial dose. One dose (bottle) consisted of 10 mL of polyvalent concentrated and modified horse antibodies treated by enzymatic digestion to neutralize the Bothrops asper venom to not less than 780 lethal dose 50 (LD50), and the Crotalus basiliscus venom to not less than 790 LD50. | Biological | F(ab')2 antivenom plus local cryotherapy., F(ab')2 antivenom. |
| Local cryotherapy.Interval cryotherapy consisted of applying a plastic bag (the size of the bag depending on the size of the lesion, approximately 28 x 46 cm) two-thirds filled with crushed ice (frapped) wrapped in a towel applied for 20 minutes every 4 hours at the site of the snakebite throughout the hospital stay. New ice bags were used after 4 hours. | Procedure or surgery | F(ab')2 antivenom plus local cryotherapy. |
Primary outcome
Distal circumference of the affected limb on hospital admission.
Time frame: Baseline.
The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity.
Proximal circumference of the affected limb on hospital admission.
Time frame: Baseline.
The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity.
Middle circumference of the affected limb on hospital admission.
Time frame: Baseline.
The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity.
Distal circumference of the affected limb on hospital admission.
Time frame: up to 24 weeks
The circumference values of the injured limb were measured in the distal circumference (site farthest from the bite with the estimated maximum degree of edema, or at the end of the limb) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
Proximal circumference of the affected limb on hospital admission.
Time frame: up to 24 weeks.
The circumference values of the injured limb were measured in the proximal circumference (5-10 cm from the site of the bite) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
Middle circumference of the affected limb on hospital admission.
Time frame: up to 24 weeks.
The circumference values of the injured limb were measured in the middle circumference (intermediate measurement between the proximal and distal diameter) on the affected extremity. The measurement was recorded at the time of the patient's hospital discharge.
1 secondary outcome
Hospital stay.
Time frame: up to 24 weeks.
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 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing F(ab)2 antivenom therapy (antivipmyn®). and Local cryotherapy. in people with Snake Bites, run by Hospital Juarez de Mexico.
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 1 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Distal circumference of the affected limb on hospital admission. (time frame: Baseline.). The study lists 6 primary outcomes in all. 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 Feb 2024.