Abdominal Regional Perfusion in Donation After Cardiac Death for Multi-Organ Transplantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLondon Health Sciences Centre

About this trial

The main purpose of this study is to increase the pool of organs available for donation by performing ARP to recondition donation after cardiac death (DCD) organs prior to transplantation. We will compare the outcomes of our ARP DCD liver transplants with historical data to determine the efficacy of this treatment compared to transplantation with standard DCD and donation after brain death (DBD) organs. We will also analyze biological samples from donors and recipients and compare them with outcome data in an effort to determine if any biological markers are able to predict the quality/success of the grafts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indications for Liver transplant include decompensated Cirrhosis of any etiology Model for End-Stage Liver Disease (MELD) score > 15 with no contraindications to liver transplant as per conventional clinical practice.

Disqualifiers

Inadequate social support for liver transplant

Non-compliance with alcohol or narcotic cessation

Evidence of uncontrolled infection

Other untreated malignancy aside from those listed above

Trial design

Design model

Single group

Treatments tested in this trial

  • Abdominal Regional Perfusion

    Device

    Abdominal Regional Perfusion

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: ARP armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary non-function

Graft failure requiring re-transplantion

Time frame
1 week
2

Early allograft dysfunction

Transient non-functioning of the liver transplant but with usual recovery to full functioning liver

Time frame
1 week
3

Ischemic Cholangiopathy

Non-anastomotic biliary stricture without other identifiable etiology

Time frame
1 week to 12 months post transplant

Secondary outcomes

1

Overall patient survival

Patient Mortality at any time post transplant

Time frame
1 and 5 years
2

Graft survival

Need for retransplant secondary to graft failure of any cause, or death

Time frame
5 years

Other outcomes

1

Biliary anastomotic stricture

Imaging or biochemical evidence of anastomotic stricture requiring intervention

Time frame
1 year
2

Biliary Anastomotic leak

Imaging or endoscopic evidence of bile leak requiring antibiotics or percutaneous drainage

Time frame
30 days
3

Length of ICU stay

Duration of post-operative stay in ICU

Time frame
30 days
4

Overall Length of stay

Overall duration of stay in hospital post-transplant

Time frame
30 days

Locations

This trial has no locations.

Sponsors and contacts

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