A trial of a clot-busting treatment in livers before transplantation

A pilot study of thrombolysis during machine perfusion of circulatory death donor livers to prevent biliary strictures

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15211703

Enrollment

Registered

2021-08-03

Start date

2021-08-01

Completion date

Unknown

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation Surgery

Interventions

Livers from donors dying following circulatory arrest (DCD donors) undergoing normothermic perfusion will receive a bolus of 10 mg alteplase and 50 ml fresh frozen plasma at the start of perfusion, fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Patient requiring a liver transplant under the care of the participating hospitals

Exclusion criteria

Exclusion criteria: 1. Inability to give consent 2. Recipient of a brain dead donor liver

Design outcomes

Primary

Measure	Time frame
Post reperfusion intra-operative blood loss. These data will be obtained from the anaesthetic records and are recored realtime on the electronic patient record	—

Secondary

Measure	Time frame
1. Total and post reperfusion intra-operative blood transfusion and blood loss measured using recorded values on electronic anaesthetic record 2. Proportion of liver perfusions resulting in a transplant measured using aptient records at the end of the study 3. Incidence of symptomatic anastomotic and non-anastomotic strictures at 6 months post-transplant determined at cholangiography; symptomatic meaning associated with raised bilirubin or ALP or cholangitis. 4. Incidence of any anastomotic or non-anastomotic stricture excluding those related to hepatic artery thrombosis determined at cholangiography 5. Incidence of “clinically relevant” non-anastomotic strictures, using the van Rijn definition (associated with raised bilirubin or ALP or cholangitis.) at 6 months 6. Incidence of post reperfusion syndrome: 30% fall in systolic BP lasting at least a minute in the first 5 minutes post reperfusion in the recipient or the need for adrenaline or doubling of noradenaline to support the circulation 7. Early allograft function (Olthoff criteria and model for early allograft function score) at 7 days 8. Incidence of hepatic artery thrombosis in the first 6 months post transplant: determined by CT or angiography 9. Incidence of acute kidney injury (RIFLE criteria) (increase in recipient serum creatinine on days 1 to 7 post transplant compared to the baseline creatinine	—

Measure

Time frame

1. Total and post reperfusion intra-operative blood transfusion and blood loss measured using recorded values on electronic anaesthetic record 2. Proportion of liver perfusions resulting in a transplant measured using aptient records at the end of the study 3. Incidence of symptomatic anastomotic and non-anastomotic strictures at 6 months post-transplant determined at cholangiography; symptomatic meaning associated with raised bilirubin or ALP or cholangitis. 4. Incidence of any anastomotic or non-anastomotic stricture excluding those related to hepatic artery thrombosis determined at cholangiography 5. Incidence of “clinically relevant” non-anastomotic strictures, using the van Rijn definition (associated with raised bilirubin or ALP or cholangitis.) at 6 months 6. Incidence of post reperfusion syndrome: 30% fall in systolic BP lasting at least a minute in the first 5 minutes post reperfusion in the recipient or the need for adrenaline or doubling of noradenaline to support the circulation 7. Early allograft function (Olthoff criteria and model for early allograft function score) at 7 days 8. Incidence of hepatic artery thrombosis in the first 6 months post transplant: determined by CT or angiography 9. Incidence of acute kidney injury (RIFLE criteria) (increase in recipient serum creatinine on days 1 to 7 post transplant compared to the baseline creatinine

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026