Human Upper Extremity Allotransplantation: F/U Protocol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Men and women who have previously received unilateral or bilateral upper limb transplants.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test
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.
Time frame
Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))2
QOL assessed for Hand Function by Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
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.
Time frame
Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))3
QOL assessed by Lawton Instrumental Activities of Daily Living (ADL/IADL) Questionnaire
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.
Time frame
Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))4
Michigan Hand Outcomes Questionnaire
Monitor function, pain, work performance, and aesthetics of hand(s). Responses from 1-5, 1 being very good and 5 being very poor
Time frame
Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))Secondary outcomes
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.
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.
Time frame
Annually for 5 years post-enrollment (±90 days)2
Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex
For immune monitoring, to screen for donor specific antibodies.
Time frame
Annually for 5 years (±90 days)3
Perform Skin Biopsy
To diagnose and assess acute rejection, Graft versus Host Disease and for surveillance of chronic rejection
Time frame
Annually for 5 years (±90 days)4
Use CT Angiography
To delineate the outline and architecture of vasculature and blood flow patterns in the limb.
Time frame
Annually for 5 years (±90 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov