<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470791</url>
  </required_header>
  <id_info>
    <org_study_id>HJM 0142/16-R</org_study_id>
    <secondary_id>HJM 0142/16-R</secondary_id>
    <nct_id>NCT04470791</nct_id>
  </id_info>
  <brief_title>Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.</brief_title>
  <official_title>Cryotherapy as a Coadjuvant in the Management of Crotaline Snakebite With F(ab')2 Antivenom: A Randomized Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Juarez de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Juarez de Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with&#xD;
      snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the&#xD;
      inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite&#xD;
      treatment with F(ab')2 antivenom is unknown.&#xD;
&#xD;
      Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with&#xD;
      snakebite treated with F(ab')2 therapy venom.&#xD;
&#xD;
      Material and methods: Subjects with snakebite envenomation accident grade II, according to&#xD;
      the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of&#xD;
      the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy&#xD;
      (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom&#xD;
      therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Blinding of the participants and interventionists was impossible, but the data analyst was blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Distal circumference of the affected limb on hospital admission.</measure>
    <time_frame>Baseline.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proximal circumference of the affected limb on hospital admission.</measure>
    <time_frame>Baseline.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Middle circumference of the affected limb on hospital admission.</measure>
    <time_frame>Baseline.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distal circumference of the affected limb on hospital admission.</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proximal circumference of the affected limb on hospital admission.</measure>
    <time_frame>up to 24 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Middle circumference of the affected limb on hospital admission.</measure>
    <time_frame>up to 24 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay.</measure>
    <time_frame>up to 24 weeks.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Snake Bites</condition>
  <arm_group>
    <arm_group_label>F(ab')2 antivenom plus local cryotherapy.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>F(ab')2 antivenom.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B: patients who received only F(ab')2 antivenom therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>F(ab)2 antivenom therapy (antivipmyn®).</intervention_name>
    <description>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.</description>
    <arm_group_label>F(ab')2 antivenom plus local cryotherapy.</arm_group_label>
    <arm_group_label>F(ab')2 antivenom.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local cryotherapy.</intervention_name>
    <description>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.</description>
    <arm_group_label>F(ab')2 antivenom plus local cryotherapy.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders and any age with a snake bite of poison grade II who were&#xD;
             admitted to the Clinical Toxicology Service of the Hospital Juárez de México.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders and any age with a snake bite of poison grade I, III or IV&#xD;
             who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Juarez de Mexico</investigator_affiliation>
    <investigator_full_name>Mario Adan Moreno Eutimio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Snake Bites</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antivenins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470791
org study id: HJM 0142/16-R
secondary id: HJM 0142/16-R
nct id: NCT04470791
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Blinding of the participants and interventionists was impossible, but the data analyst was blinded.
measure: Distal circumference of the affected limb on hospital admission.
time frame: Baseline.
description: 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.
measure: Proximal circumference of the affected limb on hospital admission.
time frame: Baseline.
description: 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.
measure: Middle circumference of the affected limb on hospital admission.
time frame: Baseline.
description: 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.
measure: Distal circumference of the affected limb on hospital admission.
time frame: up to 24 weeks
description: 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.
measure: Proximal circumference of the affected limb on hospital admission.
time frame: up to 24 weeks.
description: 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.
measure: Middle circumference of the affected limb on hospital admission.
time frame: up to 24 weeks.
description: 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.
measure: Hospital stay.
time frame: up to 24 weeks.
description: 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.
arm group label: F(ab')2 antivenom plus local cryotherapy.
arm group type: Experimental
description: Group A: patients with a Crotalus snakebite, and grade II envenomation received F(ab')2 antivenom therapy and application of local cryotherapy.
arm group label: F(ab')2 antivenom.
arm group type: Active Comparator
description: Group B: patients who received only F(ab')2 antivenom therapy.
intervention type: Biological
intervention name: F(ab)2 antivenom therapy (antivipmyn®).
description: 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.
arm group label: F(ab')2 antivenom plus local cryotherapy.
arm group label: F(ab')2 antivenom.
intervention type: Procedure
intervention name: Local cryotherapy.
description: 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.
arm group label: F(ab')2 antivenom plus local cryotherapy.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital Juarez de Mexico
investigator full name: Mario Adan Moreno Eutimio
investigator title: Principal Investigator
mesh term: Snake Bites
mesh term: Antivenins
sharing ipd: No