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

Mengya Liang

Status: Unknown

Conditions: Ischemic Preconditioning

Treatments: Procedure: cross-preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03900390

FirstSunYetSen118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Cross Ischemic Preconditioning Group

Experimental group

Description:

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

Treatment:

Procedure: cross-preconditioning

Control Group

No Intervention group

Description:

The recipients in the control group are to undergo routine cardiopulmonary bypass procedure of heart transplantation without Ischemic Preconditioning manoeuvre.