Clinical trial NCT05600634: Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation
Official title: Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Rejection
Skin Graft
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Sir Run Run Shaw Hospital
name: The First Affiliated Hospital of Air Force Medicial University
First posted: 2022-10-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.

Brief summary: The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.


Eligibility criteria: Inclusion Criteria:

1. Patients with end-stage renal disease undergoing renal transplantation;
2. 18-60 years old;
3. Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);
4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Exclusion Criteria:

1. Untreated or disseminated malignant tumor;
2. Active period of infectious diseases;
3. Serious cardiovascular disease occurred recently;
4. Combined with other important organ failure;
5. History of mental illness or cognitive impairment;

Primary outcomes:
measure: 2017 Banff Kidney Transplantation Rejection Rating
timeFrame: Through study completion, an average of 1 year
measure: 2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading
timeFrame: Through study completion, an average of 1 year
measure: Renal function testing
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Renal ultrasound diagnosis
timeFrame: Through study completion, an average of 1 year
measure: Complications
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Ari Force Medical University
state: Shannxi
city: Hangzhou
country: China
facility: First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: