TerminatedNot Applicable

Living Organ Donor Recovery Enhancement Program

Stopped: study lost funding

United States21 participantsStarted 2017-04-20

Plain-language summary

The purpose of the study is to test if using these living donor-specific pre-transplant resources would lead to a better and faster recovery post-transplant.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ages ≥ 18 years
✓. Cleared by a physician to participate in an exercise program
✓. Approved for evaluation to be a living liver or kidney donor
✓. Subjects willing and able to comply with the protocol procedures for the duration of the study, including the exercise regimen and scheduled follow-up visits
✓. Subjects who have given IRB-approved written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Exclusion criteria

✕. Any co-morbidity restricting the subject's ability to walk alone
✕. Pregnant or breast-feeding women

What they're measuring

RAND SF-36 questionnaires

Timeframe: From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.

Level of pain experienced daily

Timeframe: From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)

Duration in ICU

Timeframe: From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.

Opioid usage

Timeframe: From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.

RAND SF-36 questionnaires

Timeframe: From month 1 to month 12 post transplantation.

Duration to return of daily activities

Timeframe: From day of hospital discharge to 1 year follow up.

Incidence of Post-operative hospital re-admissions

Timeframe: From post-transplant discharge to 1 year follow-up

Trial details

NCT IDNCT03865264

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-22

View on ClinicalTrials.gov More Living Liver and Kidney Donors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Ages ≥ 18 years
✓. Cleared by a physician to participate in an exercise program
✓. Approved for evaluation to be a living liver or kidney donor
✓. Subjects willing and able to comply with the protocol procedures for the duration of the study, including the exercise regimen and scheduled follow-up visits
✓. Subjects who have given IRB-approved written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Exclusion criteria

✕. Any co-morbidity restricting the subject's ability to walk alone
✕. Pregnant or breast-feeding women

What they're measuring

RAND SF-36 questionnaires

Timeframe: From day of enrollment in the study (at least 4 weeks before surgery) up to 1 day prior to hepatectomy.

Level of pain experienced daily

Timeframe: From day of admission into ICU (post-hepatectomy) up to day of hospital discharge (4-14 days post-hepatectomy)

Duration in ICU

Timeframe: From day admission into ICU up to day of discharge to hospital floor or 14 days post hepatectomy, whichever came first.

Opioid usage

Timeframe: From day of hospital discharge (post-hepatectomy) up to 1 year post hepatectomy.

RAND SF-36 questionnaires

Timeframe: From month 1 to month 12 post transplantation.

Duration to return of daily activities

Timeframe: From day of hospital discharge to 1 year follow up.

Incidence of Post-operative hospital re-admissions

Timeframe: From post-transplant discharge to 1 year follow-up