Assessment of Hearts Deemed Unsuitable for Transplant With the Aim of Expanding the Donor Heart Pool.

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Unknown

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01780597

NewcastleNHS

Details and patient eligibility

About

The main question to be asked in this study is what is the potential for human hearts that have been deemed unacceptable for transplant, to be explanted and re-animated in a controlled, external environment to be assessed? Furthermore would the reanimated hearts be able to undergo improvement in their function in this external environment.

Ultimately this may lead to an increase the number of hearts available for transplantation.

Full description

Year on year with improvement in road safety and improvement in neurosurgery the number of ideal young brain dead donors have been declining whilst the number of more marginal donors have been increasing. The consequence of this is the number of heart transplants being performed have steadily declined.

At present there are 600 hearts from brain dead donors offered for transplant every year in the United Kingdom (UK). Of these 200 have anatomical reasons why they cannot be used for transplant such as ischaemic heart disease. 100 are transplanted and the remaining 300 hearts are judged to have inferior function which probably occurs as a direct result of brain death (Dark).

Ex vivo 'rig' testing has been developed for lungs that were judged unsuitable for transplantation. As a result several donor lungs have been 'improved' by warm perfusion on the rig to the extent that they became suitable for transplantation and so national lung transplant rates are increasing (Dark). The aim would be to develop a similar approach for the heart.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is brain dead and their relative is willing to give informed consent
• Male or Female, aged between 18 and 75 years
• Heart is not eligible for transplantation

Exclusion criteria

• Participant's relative refuses consent
• Brain dead donor whose heart is eligible for transplantation

Trial design

17 participants in 1 patient group

Organ Donors (declared Brainstem-Dead)

Description:

This group of subjects is defined as those who have previously expressed their future wish to organ donation and who have suffered events leading to declaration of brainstem-death. Furthermore these subjects will have had their hearts declined for heart transplantation on the basis of poor function.