| Primary | Percentage of Participants Completing Entire Intervention Protocol | Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions. | Participants enrolled to receive RIC during transplant and the initial four post-transplant days and who receive all 6 RIC interventions.Subjects in historical control cohort chosen as described above | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-op - Post-op day 4 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00070.96(54.04 to 87.89)
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| Secondary | Intervention-related Pain Score | Median intervention-related pain score during each of the post-operative interventions, in extubated patients who are able to communicate. Using the Numerical Rating Scale (NRS, Ferrieira-Valente MA PAIN Volume 152, 2011), patients were asked to rate their pain following the intervention on a scale of 0-10 with 0 being no pain experienced to 10 as the maximum pain felt. | Unintubated subjects were asked to rate intervention-related pain on a scale from 0-10 for each of the postoperative interventions. The maximum pain score obtained from each subject was recorded and the median score for all subjects was calculated. Scale range from 0 - 10 with 10 indicating highest sensation of pain. | Posted | | Median | Inter-Quartile Range | scores on a scale | | Post-op days 1-4 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. |
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| Secondary | Withdrawal of Consent Due to Pain | - Withdrawal of consent due to discomfort/pain in the lower extremity | Participants who withdrew consent due to pain from RIC intervention. | Posted | | Number | | participants | | Pre-op - Post-op day 7 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Subjects in this cohort were chosen via retrospective record review, and selected applying the same inclusion and exclusion criteria as in the RIC cohort. They were chosen consecutively in revere-chronological order that began at the start of the study date. Target ratio of RIC:Controls was 1:2. No matching was performed for age, sex, and model for end stage liver disease (MELD) score. |
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| Secondary | Percentage of Participants Who Developed Early Allograft Dysfunction (EAD) | Percentage of participants who developed Early Allograft Dysfunction (EAD) which is defined as:
- Aspartate Transaminase (AST) or Alanine Transaminase (ALT)> 2,000 U/L at any point within the first seven post-transplant days, or
- Total Bilirubin (TB) > 10 mg/dL on postoperative day 7,or
- International Normalized Ratio (INR)> 1.6 on postoperative day 7.
| Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation | Posted | | Number | | percentage of participants | | Post-op days 0-7 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | |
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| Secondary | Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI) | Percentage of Participants who developed Prolonged Respiratory Insufficiency (PRI) defined as:
- Ventilator support for >2 postoperative days after transplant, or
- Reintubation after extubation, within 7 days of transplant. Patients who require brief re-intubation for an endoscopic, radiologic, or surgical procedure would not be considered to have PRI if they are extubated within 2 days of the end of the procedure.
| Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation | Posted | | Number | | percentage of participants | | Post-op days 0-7 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort |
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| Secondary | Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3 | Percentage of participants who developed Acute Kidney Injury (AKI) Based on Kidney Disease - Improving Global Outcomes (KDIGO) criteria, AKI criteria are: Stage 2: - 2.0-2.9 fold rise in serum creatinine from baseline Stage 3:
- > 3.0 fold rise in serum creatinine from baseline, or
- Serum creatinine of > 4.0 mg/dL, with an acute (<48 hours) increase of 0.3 mg/dL in serum creatinine or subacute (< 7 days) increase in serum creatinine of 0.5 mg/dL, or
- Initiation of renal replacement therapy.
| Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation | Posted | | Number | | percentage of participants | | Post-op days 0-7 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 |
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| Secondary | Time to Dialysis Discontinuation | In patients who are receiving dialysis pre-op, time to discontinuation of dialysis, if occurring within 90 days of transplantation. | Time to discontinuation of dialysis | Posted | | Median | Inter-Quartile Range | days | | Post-op days 0-90 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Presence of Clavien-Dindo Grade IIIb or Higher Complications | Percentage of patients with Clavien-Dindo >/= grade III b complications (Dindo D, Demartines N, Clavien P, Annals of Surgery 2004). The Clavien-Dindo Complications grade ranges from Grade I (Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside) to Grade V (Death). Grade IIIb would be any intervention requiring general anesthesia. | | Posted | | Number | | percentage of participants | | Post-op days 0-30 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | |
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| Secondary | Clavien-Dindo Grade IIIb or Higher - Number of Complications | In patients with Clavien-Dindo >/= IIIb complications, number of such complications per patient. | | Posted | | Median | Inter-Quartile Range | Complications | | Post-op days 0-30 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Intensive Care Unit (ICU) Length of Stay (LOS) | Number of days in ICU post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is transferred out of ICU, dies, or post-op day 90, whichever is soonest. | Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation | Posted | | Median | Inter-Quartile Range | days | | Post-op days 0 up to 90 days | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Hospital LOS | Number of days in hospital post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is leaves the hospital, dies, or post-op day 90, whichever is soonest. | | Posted | | Median | Inter-Quartile Range | days | | Post-op days 0 up to 90 days | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Liver Allograft Survival | Percentage of patients with functioning allograft at 90 days post-transplant | Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation | Posted | | Number | | percentage of participants | | Post-op day 90 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Patient Survival | Percentage of patients alive at 90 days post-transplant | | Posted | | Number | | percentage of participants | | Post-op day 90 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. | | OG001 | Historical Control Cohort | Historical matched recipient controls |
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| Secondary | Number of Subjects Not Completing Intervention Protocol | Number of subjects that received fewer than 6 interventions,. | Number of subjects who completed < 6 interventions | Posted | | Number | | participants | | Pre-op - Post-op day 4 | | | | ID | Title | Description |
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| OG000 | Remote Ischemic Conditioning (RIC) Group | Participants will receive RIC during transplant and the initial four post-transplant days. During transplant: first intervention after induction of anesthesia but before commencing surgery and the second at the conclusion of the procedure. After transplant: RIC applied daily during the first four consecutive postoperative days. Pneumatic tourniquet will be used to induce RIC Remote Ischemic Conditioning (RIC): Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh. Pneumatic tourniquet: Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions. |
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