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Copperhead Envenomation Observational Study

10. maj 2013 opdateret af: BTG International Inc.

Observational Study of Recovery From Copperhead Snake Envenomation

The primary objective of the study is to evaluate the responsiveness and utility of several clinical outcome assessments in the setting of copperhead snakebite. The secondary objective is to characterize the clinical course of signs, symptoms and impairment during the recovery phase of copperhead snakebite.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

This observational study will document the patient's recovery from copperhead snakebite. All care provided will be at the discretion of the treating physician in accordance with the local standard of care.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky Chandler Medical Center
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71103
        • LSU Health Sciences Center
    • Michigan
      • Jackson, Michigan, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 76104
        • Washington University
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Medical Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • Vidant Health
    • Texas
      • Bryan, Texas, Forenede Stater, 77802
        • St. Joseph Regional Health Center
      • Ft. Worth, Texas, Forenede Stater, 76104
        • Harris Methodist Hospital
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Hospital
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia, Blue Ridge PC
      • Richmond, Virginia, Forenede Stater, 23219
        • Virginia Commonwealth University Richmond

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Males and non-pregnant females at least 18 yrs of age with evidence of copperhead envenomation on an extremity distal to the knee or elbow that present for care at a health care facility within 24 hours of envenomation.

Beskrivelse

Inclusion Criteria:

  • Envenomation by a copperhead snake
  • Presentation for care at a health care facility within 24 hrs of envenomation
  • Envenomation on an extremity distal to the knee or elbow
  • Clinical evidence of venom effect (limb swelling and/or tenderness)
  • Enrollment can be completed within 48 hrs of envenomation prior to discharge
  • Patient is willing and able to complete follow-up schedule of assessments
  • Patient is able to read, comprehend and sign IRB approved informed consent
  • Patient is able to read and comprehend written assessment tools
  • Patient is at least 18 yrs old
  • Patient is sober, competent and able to complete verbal and written informed consent

Exclusion Criteria:

  • Patient is pregnant or breastfeeding
  • Patient is a prisoner
  • Patient has distracting injury, condition with acute pain or functional impairment, and/or is unable to make a reliable self-report of status
  • Patient has had previous snake envenomation to any body area within 30 days prior to screening/enrollment, regardless of whether antivenom was administered
  • Patient had an acute traumatic or medical event, surgery, or exacerbation of pre-existing medical or surgical condition effecting the envenomated extremity within 30 days prior to screening/enrollment
  • Patient has participated in a clinical study involving and investigational pharmaceutical product or device within 3 months prior to screening that may have impact on clinical outcomes of snakebite
  • Patient has previously participated in this study
  • Patient is, in the investigator's opinion, otherwise unsuitable for participation. Note: Treatment with antivenom prior to eligibility evaluation is not an exclusion criterion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Patient Global Assessment of Recovery (PGAR)
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Pain Rating Scale (NPRS)
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Numeric Swelling Score (NSS)
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
SF36v2 (Acute Version)
Tidsramme: Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
Time of Discharge, Day 7, Day, 14, Day 21, and Day 28
Swelling Figure-of-8 Measurement
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Grip Strength
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Walking Speed
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Patient Global Impression of Change (PGIC)
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Return to Work/School/ADLs
Tidsramme: Day 3, Day 7, Day 14, Day 21, and Day 28
Day 3, Day 7, Day 14, Day 21, and Day 28
Patient-Specific Functional Scale (PSFS)
Tidsramme: Day 3, Day 7, Day 14, Day 21, and Day 28
Day 3, Day 7, Day 14, Day 21, and Day 28
WPAI:SHP V2
Tidsramme: Day 3, Day 7, Day 14, Day 21, and Day 28
Day 3, Day 7, Day 14, Day 21, and Day 28
Disorders of the Arm, Shoulder, and Hand (DASH)
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Lower Extremity Functional Scale
Tidsramme: Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28
Time of Discharge, Day 3, Day 7, Day 14, Day 21, and Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2012

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

25. juli 2012

Først indsendt, der opfyldte QC-kriterier

26. juli 2012

Først opslået (Skøn)

27. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2013

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • BTG-PR005-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Copperhead Snake Envenomation

3
Abonner