Clinical trial NCT03900390: The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
Official title: The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Preconditioning
Keywords: heart transplantation
ischemia-reperfusion injury
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, a large number of studies confirmed the protective effect of ischemic preconditioning on myocardium against ischemia/reperfusion injury, but the clinical data of the effectiveness of ischemic preconditioning in heart transplantation is still missing. Inspired by the promising data of ischemic preconditioning from the previous reports, the investigators firstly introduce a novel method of cross ischemic preconditioning technique to prevent ischemia/reperfusion injury to heart transplant recipients.

This study will evaluate whether this cross-preconditioning technique would attenuate ischemia/ reperfusion injury to the heart transplant recipients, reduce Intensive Care Unit(ICU) and total hospitalization stays and the incidence of cardiovascular adverse events and improve the long-term survival outcomes.

Detailed description: Patients receiving heart transplantation are randomly assigned into the cross ischemic preconditioning (CICP) intervention group and the control group. (the Statistical Analysis System (SAS) software was used to generate a random number table and randomly divided into two groups). After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions.

The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation.

Eligibility criteria: Inclusion Criteria:

1. Patients who underwent heart transplantation；
2. Signed informed consent.

Exclusion Criteria:

1. Systemic active infection;
2. Refractory respiratory failure or renal failure;
3. Severe systemic diseases with limited survival time.
4. ABO blood groups incompatibility
5. positive serum HIV antibody;
6. drug or alcohol abusing;
7. Mentally ill;
8. Recent history of severe pulmonary embolism
9. Have not signed informed consent.

Primary outcomes:
measure: serum troponin T/ creatine kinase-MB level
timeFrame: 3days
measure: Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively
timeFrame: 1year
Secondary outcomes:
measure: inotrope score
timeFrame: 3days
measure: serum creatinine level
timeFrame: 3days
measure: ICU time
timeFrame: up to 2 weeks
measure: 6-minute walk test
timeFrame: 2weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of sun yat-sen university
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Zhongkai Wu
role: STUDY_DIRECTOR
References: