OCS Liver PROTECT Continued Access Protocol

Launched by TRANSMEDICS · Dec 2, 2019

Keywords

ClinConnect Summary

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effective...

Gender

ALL

Eligibility criteria

• Recipient Inclusion Criteria:
• • Registered primary liver transplant candidate, male or female
• • Age ≥ 18 years
• • Signed (1) written informed consent document and (2) authorization to use and disclose protected health information
• Exclusion Criteria:
• • Acute, fulminant liver failure
• • Prior solid organ or bone marrow transplant
• • Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \> 3 mg/dl for \> 2 weeks and/or requiring hemodialysis
• • Multi-organ transplant
• • Ventilator dependent
• • Dependent on \> 1 IV inotrope to maintain hemodynamics
• • Donor Inclusion Criteria
• • Donor age ≥ 40 years, or
• • Expected cross-clamp time ≥ 6 hours, or
• • Donor after circulatory death (DCD) with age ≤ 55 years, or
• • Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval
• • Donor Exclusion Criteria
• • Living donors
• • Liver intended for split transplants
• • Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C)
• • Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
• • Donor livers with macrosteatosis of \> 40% based on retrieval biopsy readout.