Hand Transplantation: Functional and Quality of Life Outcomes

Amputation; Traumatic, Hand Clinical Trial

Official title:

VCA (Hand Transplantation): Functional and Quality of Life Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02331355
• Other study ID #: HUM00078607
• Status: Withdrawn
• Start date: April 2016
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care. Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.

Description:

Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields. Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments. Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.

Exclusion Criteria:

• Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Arm, Upper
• Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow
• Amputation; Traumatic, Arm: Forearm, at Elbow Level
• Amputation; Traumatic, Hand
• Amputation; Traumatic, Hand, Both

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost and utilization information	cost and utilization of service will be tracked	Transplant through end of study (5 years)
Primary	Allograft survival	Graft survival will be evaluated at transplant, days 14, then monthly in year 1, then yearly years 2-5	Transplant through end of study (5 years)
Secondary	Immunosuppression requirements	immunosuppression will be documented throughout study	Transplant through end of study (5 years)
Secondary	Allograft rejection	Skin and muscle biopsies will be performed days 14, then monthly in year 1, then yearly years 2-5. Donor specific antibody will also be measured at these timepoints	Transplant through end of study (5 years)
Secondary	Allograft Function	Outcomes questionnaires will be completed by patient at post-transplant 3, 6, 12 months, and every year thereafter up to 5 years	Transplant through end of study (5 years)
Secondary	Quality of life	SF-36 survey results will be collected before transplant and at various time points post transplant	Transplant through end of study (5 years)