Non-ischaemic Heart Preservation Versus Standard Cold Storage in Human Heart Transplantation

NAEnrolling by invitationINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Transplant; Failure, Heart
Interventions
DEVICE

Non-ischemic heart preservation (NIHP)

The device is a miniaturized and fully automated heart-lung machine, housed in a portable device (weight 32 kg), that enables transportation between hospitals. The reservoir is filled with 2.5 liters of the perfusion solution plus approximately 500 mL compatible washed and leucocyte-filtered red blood cells from the hospital blood bank. The NIHP system software is adjusted to maintain a mean blood pressure of 20-25 mmHg in the aortic root, giving a coronary flow between 150 mL/min and 250 mL/min.

DEVICE

Standard ischemic cold static storage (SCS)

The device is a cool box that enables transportation between hospitals. The heart is stored on ice slush in the box at a temperature of approximately 4-8 °C.

Trial Locations (1)

22185

Skane University Hospital, Lund

All Listed Sponsors
collaborator

Lund University

OTHER

collaborator

Skane University Hospital

OTHER

lead

Region Skane

OTHER