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Идёт набор NCT03400345

Human Upper Extremity Allotransplantation: F/U Protocol

— Наблюдательное Amputation, Traumatic Wounds and Injury Hand Injuries

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Amputation, Traumatic, Wounds and Injury, Hand Injuries. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Human Upper Extremity Allotransplantation: Transplanted Patient Follow-Up Protocol

Обзор

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.

Первичные конечные точки

  • Quality of life (QOL) for upper extremity transplant recipients via Functional Assessment with rehabilitation using Carroll Test [Срок оценки: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))]
  • QOL assessed for Hand Function by Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire [Срок оценки: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))]
  • QOL assessed by Lawton Instrumental Activities of Daily Living (ADL/IADL) Questionnaire [Срок оценки: Change from baseline QOL at end of study (approximately 5 years post-enrollment (±90 days))]
  • Michigan Hand Outcomes Questionnaire [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Short Musculoskeletal Function Assessment (SMFA) [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Brief Pain Inventory (Short Form) (BPISF) [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Quality of life assessed for Psychological Measures by Brief Symptom Inventory [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Psychological Measures by Satisfaction with Life Scale (SWLS) [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Psychological Measures assessed by Affect Balance Scale (ABS) [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
  • Psychological Measures assessed by NEO Five-Factor Inventory (NEO-FFI) [Срок оценки: Change from baseline to end of study (approximately 5 years post-enrollment (±90 days))]
Вторичные конечные точки (5)
  • 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. [Срок оценки: Annually for 5 years post-enrollment (±90 days)]
  • Immunology- antibody testing by obtaining donor specific antibodies (DSA) by Luminex [Срок оценки: Annually for 5 years (±90 days)]
  • Perform Skin Biopsy [Срок оценки: Annually for 5 years (±90 days)]
  • Use CT Angiography [Срок оценки: Annually for 5 years (±90 days)]
  • Magnetic Resonance (MR) Neurography [Срок оценки: Annually for 5 years (±90 days)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Johns Hopkins University School of Medicine — Baltimore

Публикации

  • Shores JT, Malek V, Lee WPA, Brandacher G. Outcomes after hand and upper extremity transplantation. J Mater Sci Mater Med. 2017 May;28(5):72. doi: 10.1007/s10856-017-5880-0. Epub 2017 Mar 30. PMID 28361279
  • Shores JT, Brandacher G, Lee WPA. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. 2015 Feb;135(2):351e-360e. doi: 10.1097/PRS.0000000000000892. PMID 25401735
  • Adler BL, Albayda J, Shores JT, Lee WPA, Brandacher G, Bingham CO 3rd. Erosive Rheumatoid Arthritis After Bilateral Hand Transplantation. Ann Intern Med. 2017 Aug 1;167(3):216-218. doi: 10.7326/L16-0588. Epub 2017 Jun 27. No abstract available. PMID 28654973

Идентификаторы

NCT: NCT03400345 · NA_00068053

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗