The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study of Potency of Cross-preconditioning to Prevent Ischemic-reperfusion Injury for Heart Transplantation Recipient

Conditions
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Ischemic Preconditioning

Intervention / Treatment
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* Procedure: cross-preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent heart transplantation； Signed informed consent. Exclusion Criteria: Systemic active infection; Refractory respiratory failure or renal failure; Severe systemic diseases with limited survival time. ABO blood groups incompatibility positive serum HIV antibody; drug or alcohol abusing; Mentally ill; Recent history of severe pulmonary embolism Have not signed informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cross Ischemic Preconditioning Group<br>the ascending aorta of the CIP group will be crossclamped to cease the blood supply for 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions | Procedure: cross-preconditioning<br>* 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.<br>|
| No Intervention: Control Group<br>The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum troponin T/ creatine kinase-MB level | troponin T/ creatine kinase-MB at definitive time points ( baseline, crossclamping, reperfusion, 6,24,48 and 72 hours postoperatively) | 3days | 
| Number of Participants with major adverse cardiacand cerebrovascular events (MACCE) in one year postoperatively | MACCE include death from cardiovascular causes, nonfatal myocardial infarction, coronary revascularization, or strok | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inotrope score | calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery | 3days | 
| serum creatinine level | grade 1, 2, or 3 acute kidney injury within 72 hours after surgery (assessed on the basis of the increase in the serum creatinine level according to the International Kidney Disease: Improving Global Outcomes classification | 3days | 
| ICU time | duration of stay in the intensive care unit and hospital | up to 2 weeks | 
| 6-minute walk test | distance on the 6-minute walk test two weeks after surgery | 2weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart transplantation, ischemia-reperfusion injury