BridgeMD
New treatment option for Liver Transplantation
Official title Immunometabolism of Machine Perfusion Strategies
ClinicalTrials.gov ID: NCT06371924
What this study is testing
- What it's testing
- There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI).
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Donor 1. DCD category III donors considered for abdominal organs-only retrieval.
- Donor age ≥18 years.
- Retrieval procedure allocated to KCH or UHB NORS teams.
- Donor liver accepted for a patient at KCH or UHB transplant waiting list via the standard offering process.
- Functional donor warm ischaemia (defined as a period between the systolic blood pressure \<50mmHg and aortic cold flush) ≤30 minutes.
You likely can't join if
- Donor exclusion criteria
- Donor is HIV, hepatitis B (HBV HbsAg) or hepatitis C (HCV RNA) positive. HBV anti-Hbc positive donors are acceptable.
- Macroscopic evidence of fibrosis.
- Liver weight \>2.5 kg.
- Retrieval of cardiothoracic organs intended for transplantation.
- Any medical condition that, in the opinion of the principal investigator, would interfere with safe completion of the trial. Transplant recipient...
See the full eligibility criteria
- Donor 1. DCD category III donors considered for abdominal organs-only retrieval.
- Donor age ≥18 years.
- Retrieval procedure allocated to KCH or UHB NORS teams.
- Donor liver accepted for a patient at KCH or UHB transplant waiting list via the standard offering process.
- Functional donor warm ischaemia (defined as a period between the systolic blood pressure \<50mmHg and aortic cold flush) ≤30 minutes.
- Donor BMI \<35kg/m2.
- Predicted cold ischaemic time \<8 hours.
- Donor family has given consent to use donated liver for research. Transplant recipient 1. Recipients 18 years of age or older.
- Listed on an elective transplant waiting list.
- First liver transplantation.
- Suitable to receive a DCD graft based on the liver listing MDT.
- Willingness to consent for the study participation.
- Donor exclusion criteria
- Donor is HIV, hepatitis B (HBV HbsAg) or hepatitis C (HCV RNA) positive. HBV anti-Hbc positive donors are acceptable.
- Macroscopic evidence of fibrosis.
- Liver weight \>2.5 kg.
- Retrieval of cardiothoracic organs intended for transplantation.
- Any medical condition that, in the opinion of the principal investigator, would interfere with safe completion of the trial. Transplant recipient exclusion criteria
- High-risk surgical candidates (i.e. presence of extensive portomesenteric thrombosis, previous complex upper abdominal surgery).
- Patients receiving super-urgent transplantation for acute and acute-on-chronic liver failure.
- Patients unable to give full informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, United Kingdom; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.