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Human Upper Extremity Allotransplantation: F/U Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400345
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Upper extremity allotransplantation is a new procedure which is becoming more common in the United States. Ongoing data collection for research purposes is vital to the long-term assessment as to the safety of the procedure and accompanying immunosuppression protocol, as well as quantifying patient outcomes and changes in quality of life. For these reasons, The Johns Hopkins Hand/Arm Transplantation Team is interested in enrolling transplanted patients in a follow-up protocol to continue collecting informative data to further the field of vascularized composite allotransplantation.

Condition or disease
Amputation, Traumatic Wounds and Injury Hand Injuries

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2026



Primary Outcome Measures :
  1. Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]
    Measures Grasp, Grip and Pinch Strength, Range of motion - Active & Passive. During rehabilitation sessions in clinic using activities resembling everyday tasks such as pouring water, opening/closing zippers and buttons, lifting blocks of different weight. Carroll test contains 33 questions and is scored from 0-3, 0- can perform no part of test, 1- performs test partially, 2-completes test, but takes abnormally long time or has great difficulty, and 3- performs tests normally.

  2. QOL assessed for Hand Function by Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]
    The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). 1 indicating no difficulty and 5 indicating unable perform the function.

  3. QOL assessed by Lawton Instrumental Activities of Daily Living (ADL/IADL) Questionnaire [ Time Frame: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days)) ]
    Questionnaire to asses Physical and instrumental activities for daily living. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). The scale will vary along a range of levels of competence- without any help, with some help, or does he need someone for the activities.

  4. Michigan Hand Outcomes Questionnaire [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    Monitor function, pain, work performance, and aesthetics of hand(s). Responses from 1-5, 1 being very good and 5 being very poor

  5. Short Musculoskeletal Function Assessment (SMFA) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    The SMFA consists of two sections: 34 questions covering the assessment of the patients function and 12 questions covering how bothered patients are by their symptoms. Each question is scored 1 for no problems/no difficulty/not bothered (depending on the question) to 5 for unable to do a task/symptoms all the time/being greatly bothered.

  6. Brief Pain Inventory (Short Form) (BPISF) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    BPISF assesses the severity of pain and its impact on functioning. It is scored from 0 to 10, 0 indicating no pain, does not interfere to 10 indicating pain as bad as you can imagine, completely interferes.

  7. Quality of life assessed for Psychological Measures by Brief Symptom Inventory [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    Brief Symptom Inventory questionnaire evaluates psychological distress and psychiatric disorders. It consists of 53-item self-report inventory in which participants rate the extent to which they have been bothered. 5-point rating scale, 0 indicating not at all bothered to 4 extremely bothered.

  8. Psychological Measures by Satisfaction with Life Scale (SWLS) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates Strongly disagree to 7 indicating strongly agree.

  9. Psychological Measures assessed by Affect Balance Scale (ABS) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    ABS is a 10-item questionnaire that assess positive and negative affect as indicators of life satisfaction and/or well-being. Score range from 0-4. 0 indicating the feeling never affected to 4, where the feeling is affected always.

  10. Psychological Measures assessed by NEO Five-Factor Inventory (NEO-FFI) [ Time Frame: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days)) ]
    NEO-FFI is used to examine personality traits. Questions consists of 60 items. Items are scored from Strongly disagree to Strongly agreed


Secondary Outcome Measures :
  1. The efficacy of various immunosuppression regimens via ImmuKnow Assay/Cylex including immunomodulatory protocols (aka - Pittsburgh Protocol, Starzl Protocol), for maintenance of unilateral and bilateral upper extremity allotransplants. [ Time Frame: Annually for 5 years post-enrollment (±90 days) ]
    For immune monitoring, to test cell mediated immunity. Value of ≤ 225 ng/mL indicates Low immune cell response, 226-524 ng/mL- Moderate Immune response, ≥525 ng/mL- High Immune cell Response.

  2. Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex [ Time Frame: Annually for 5 years (±90 days) ]
    For immune monitoring, to screen for donor specific antibodies.

  3. Perform Skin Biopsy [ Time Frame: Annually for 5 years (±90 days) ]
    To diagnose and assess acute rejection, Graft versus Host Disease and for surveillance of chronic rejection

  4. Use CT Angiography [ Time Frame: Annually for 5 years (±90 days) ]
    To delineate the outline and architecture of vasculature and blood flow patterns in the limb.

  5. Magnetic Resonance (MR) Neurography [ Time Frame: Annually for 5 years (±90 days) ]
    To help assess progression of nerve regeneration distal to the site of transplanted nerve coaptation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women who have previously received unilateral or bilateral upper limb transplants.
Criteria

Inclusion Criteria:

  • Males and females 5 or more years post-unilateral or bilateral upper limb transplantation.
  • Completes the protocol informed consent form.
  • Consents to sample collection and storage (biopsies).
  • USA citizen or equivalent.
  • Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Exclusion Criteria:

  • Candidate has not received an upper extremity allotransplant.
  • Any reason the study team thinks would cause the participant to be noncompliant or would put the patient at unacceptable risk if enrolled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400345


Contacts
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Contact: Jane Littleton, C.R.N.P 410-955-6875 jlittl38@jhmi.edu
Contact: Vidhi Javia, B.S. 443-287-7848 vjavia1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Carisa M Cooney, MPH, CCRP    443-287-4629    ccooney3@jhmi.edu   
Contact: Vidhi Javia, BS    443-287-7848    vjavia1@jhmi.edu   
Sub-Investigator: Gerald Brandacher, MD         
Sub-Investigator: Damon S Cooney, MD, PhD         
Principal Investigator: Jaimie Shores, MD         
Sub-Investigator: Richard J Redett, MD         
Sub-Investigator: W. P. Andrew Lee, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jaimie Shores, M.D. Johns Hopkins University

Additional Information:
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03400345    
Other Study ID Numbers: NA_00068053
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pooled patient data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Hand Transplant
composite tissue allograft (CTA)
Vascularized Composite Allotransplantation (VCA)
Amputation
Upper Limb
Immunosuppression
Additional relevant MeSH terms:
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Hand Injuries
Amputation, Traumatic
Wounds and Injuries