OCS Liver PROTECT Trial: Preserving and Assessing Donor L... | NCT02522871

Label	Type	Description	Intervention Names
OCS Liver System	Experimental	OCS Liver System	Device: OCS™ Liver System
Control	Other	Standard of care (ice)	Other: Control

Name	Type	Description	Arm Group Labels	Other Names
OCS™ Liver System	Device		OCS Liver System
Control

Measure	Description	Time Frame
Participants With Early Liver Allograft Dysfunction (EAD)	Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level > 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)	7 days
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient	Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.	30 days

Measure	Description	Time Frame
Patient Survival at Day 30 After Transplant	Patient survival at day 30 after transplantation	30 days after transplant
Patient Survival at Initial Hospital Discharge Post Liver Transplant	Patient survival at initial hospital discharge post liver transplantation

Measure	Description	Time Frame
Evidence of Ischemic Biliary Complications Diagnosed at 6 Months	Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 6 Months Follow-up Visit	6 months post transplant
Evidence of Ischemic Biliary Complications Diagnosed at 12 Months

Name	Affiliation	Role
Ahmed Elbetanony, MD	TransMedics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego		La Jolla	California	92037	United States
Scripps

PubMed Identifier	Type	Citation	Retractions
34985503	Derived	Markmann JF, Abouljoud MS, Ghobrial RM, Bhati CS, Pelletier SJ, Lu AD, Ottmann S, Klair T, Eymard C, Roll GR, Magliocca J, Pruett TL, Reyes J, Black SM, Marsh CL, Schnickel G, Kinkhabwala M, Florman SS, Merani S, Demetris AJ, Kimura S, Rizzari M, Saharia A, Levy M, Agarwal A, Cigarroa FG, Eason JD, Syed S, Washburn WK, Parekh J, Moon J, Maskin A, Yeh H, Vagefi PA, MacConmara MP. Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant: The OCS Liver PROTECT Randomized Clinical Trial. JAMA Surg. 2022 Mar 1;157(3):189-198. doi: 10.1001/jamasurg.2021.6781.

ID	Title	Description
FG000	OCS Liver System	Organ Care System (OCS) Liver
FG001	Control	Ischemic cold storage (ICS)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 20, 2016	Dec 9, 2022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00027 OG00144 OG00227 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		one-sided Farrington and Manning		<0.0001		Difference of Proportion	-0.132			1-Sided	95		-0.049					Non-Inferiority	non-inferiority margin = 0.075
OG002 OG003		one-sided Farrington and Manning

Primary

Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient

Defined as the average number of LGRSAEs (Liver Graft-Related Serious Adverse Event) up to the 30-day follow-up after transplantation per patient.

As Treated Population

Posted

Mean

Standard Deviation

Events per patient

30 days

ID	Title	Description
OG000	OCS Liver	Organ Care System (OCS) Liver
OG001	Control	Ischemic cold storage (ICS)

Units	Counts
Participants	OG000

Secondary

Patient Survival at Day 30 After Transplant

Patient survival at day 30 after transplantation

Posted

Count of Participants

Participants

30 days after transplant

ID	Title	Description
OG000	OCS Liver - Per-protocol	Organ Care System (OCS) Liver - Per-protocol
OG001	Control - Per-protocol	Ischemic cold storage (ICS) - Per-protocol
OG002	OCS Liver - mITT	Organ Care System (OCS) Liver - mITT
OG003	Control - mITT	Ischemic cold storage (ICS) - mITT

Units	Counts
Participants

Secondary

Patient Survival at Initial Hospital Discharge Post Liver Transplant

Patient survival at initial hospital discharge post liver transplantation

Posted

Count of Participants

Participants

at initial hospital discharge post liver transplant, an average of 11 days

ID	Title	Description
OG000	OCS Liver - Per-protocol	Organ Care System (OCS) Liver - Per-protocol
OG001	Control - Per-protocol	Ischemic cold storage (ICS) - Per-protocol
OG002	OCS Liver - mITT	Organ Care System (OCS) Liver - mITT
OG003	Control - mITT	Ischemic cold storage (ICS) - mITT

Units	Counts
Participants

Other Pre-specified

Evidence of Ischemic Biliary Complications Diagnosed at 6 Months

Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 6 Months Follow-up Visit

per-protocol population

Posted

Count of Participants

Participants

6 months post transplant

ID	Title	Description
OG000	OCS Liver System	Organ Care System (OCS) Liver
OG001	Control	Ischemic cold storage (ICS)

Units	Counts
Participants	OG000

Other Pre-specified

Evidence of Ischemic Biliary Complications Diagnosed at 12 Months

Number and percentage of Participants with Ischemic Biliary Complications from Day of Transplant through 12 Months Follow-up Visit

per-protocol population

Posted

Count of Participants

Participants

12 months post transplant

ID	Title	Description
OG000	OCS Liver System	Organ Care System (OCS) Liver
OG001	Control	Ischemic cold storage (ICS)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0003 events3 affected153 at risk EG0011 events1 affected146 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Atrial Fibrillation	Cardiac disorders	Systematic Assessment	EG0003 events3 affected153 at risk EG0014 events4 affected146 at risk
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Intracardiac thrombus	Cardiac disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0013 events2 affected146 at risk
Myocardial ischaemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0013 events3 affected146 at risk
Coeliac artery compression syndrome	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Duodenal perforation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected146 at risk
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Intravascular haemolysis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Arrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected146 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Intestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Peritonitis	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Pneumoperitoneum	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Umbilical hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Catheter site haemorrhage	General disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Oedema	General disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Pyrexia	General disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0014 events4 affected146 at risk
Bile duct obstruction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Bile duct stenosis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Biliary ischaemia	Hepatobiliary disorders	Systematic Assessment	EG0004 events4 affected153 at risk EG00114 events14 affected146 at risk
Cholangitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Hepatic artery stenosis	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0014 events4 affected146 at risk
Hepatic artery thrombosis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Hepatic necrosis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Portal vein occlusion	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Portal vein stenosis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Portal vein thrombosis	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0012 events2 affected146 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Transplant rejection	Immune system disorders	Systematic Assessment	EG0005 events5 affected153 at risk EG0018 events7 affected146 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected146 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Fungal peritonitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected146 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected153 at risk EG0010 events0 affected146 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Biliary anastomosis complication	Injury, poisoning and procedural complications	Systematic Assessment	EG00013 events13 affected153 at risk EG0016 events6 affected146 at risk
Drug toxicity	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected153 at risk EG0012 events2 affected146 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Mental status changes postoperative	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected146 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected153 at risk EG00111 events11 affected146 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events5 affected153 at risk EG0017 events7 affected146 at risk
Procedural complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected146 at risk
Seroma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Spinal fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Liver function test abnormal	Investigations	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected146 at risk
Failure to thrive	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected146 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Malnutrition	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected146 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events1 affected146 at risk
Convulsion	Nervous system disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0015 events5 affected146 at risk
Demyelinating polyneuropathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Hepatic encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Metabolic encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Migraine	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0014 events4 affected146 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0011 events1 affected146 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG00011 events11 affected153 at risk EG0017 events7 affected146 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0012 events2 affected146 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0014 events4 affected146 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected153 at risk EG0010 events0 affected146 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected146 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Reexpansion pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected153 at risk EG0013 events3 affected146 at risk
Hernia repair	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Incisional drainage	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Inguinal hernia repair	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Air embolism	Vascular disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Artery dissection	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Haemorrhage	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0012 events2 affected146 at risk
Hypovolaemic shock	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Jugular vein thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0010 events0 affected146 at risk
Reperfusion injury	Vascular disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Shock	Vascular disorders	Systematic Assessment	EG0000 events0 affected153 at risk EG0011 events1 affected146 at risk
Vascular shunt	Vascular disorders	Systematic Assessment	EG0001 events1 affected153 at risk EG0011 events1 affected146 at risk

ID	Title	Description
BG000	OCS Liver	Organ Care System (OCS) Liver
BG001	Control	Ischemic cold storage (ICS)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	OCS Liver System	Organ Care System (OCS) Liver	9	153	82	153	0	0
EG001	Control	Ischemic Cold Storage (ICS)	10	147	72	146	0	0