Trial Outcomes & Findings for Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) (NCT NCT02251041)
NCT ID: NCT02251041
Last Updated: 2024-08-23
Results Overview
peak AST is defined as the highest value of serum AST within 72 hours following liver transplantation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
within 72 hours following liver transplantation
Results posted on
2024-08-23
Participant Flow
Of 143 enrolled participants, 93 were randomized. Reasons for exclusion of enrolled participants was : * Patients deceased before transplantation (on waiting list) * Patients not eligible anymore for transplantation * Included in other clinical trials * Change from single liver transplantation to combined transplantation (liver-kidney)
Participant milestones
| Measure |
Combined Drug Approach
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
15
|
4
|
Reasons for withdrawal
| Measure |
Combined Drug Approach
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Overall Study
Did not receive intervention
|
15
|
4
|
Baseline Characteristics
Race data were not collected from participants
Baseline characteristics by cohort
| Measure |
Combined Drug Approach
n=38 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controls
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=38 Participants
|
60 years
n=36 Participants
|
60 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=38 Participants
|
11 Participants
n=36 Participants
|
21 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=38 Participants
|
25 Participants
n=36 Participants
|
53 Participants
n=74 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
Race data were not collected from participants
|
|
Donor age
|
57 years
n=38 Participants
|
59 years
n=36 Participants
|
59 years
n=74 Participants
|
|
Donor type
Donation after Brain Death
|
26 Participants
n=38 Participants
|
23 Participants
n=36 Participants
|
49 Participants
n=74 Participants
|
|
Donor type
Donation after Circulatory Death
|
12 Participants
n=38 Participants
|
13 Participants
n=36 Participants
|
25 Participants
n=74 Participants
|
|
Warm ischemia time if Donation after Circulatory Death
|
17 minutes
n=12 Participants • Only livers from Donation after Circulatory Death donors undergo (donor) warm ischemia. So this is only measured and reported in the DCD population (see donor type)
|
16 minutes
n=13 Participants • Only livers from Donation after Circulatory Death donors undergo (donor) warm ischemia. So this is only measured and reported in the DCD population (see donor type)
|
17 minutes
n=25 Participants • Only livers from Donation after Circulatory Death donors undergo (donor) warm ischemia. So this is only measured and reported in the DCD population (see donor type)
|
|
Intensive Care Unit Length of stay (donor)
|
3 days
n=38 Participants
|
4 days
n=36 Participants
|
4 days
n=74 Participants
|
|
Donor cause of death
Trauma
|
6 Participants
n=38 Participants
|
11 Participants
n=36 Participants
|
17 Participants
n=74 Participants
|
|
Donor cause of death
Cerebrovascular accident
|
20 Participants
n=38 Participants
|
11 Participants
n=36 Participants
|
31 Participants
n=74 Participants
|
|
Donor cause of death
Anoxia
|
0 Participants
n=38 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=74 Participants
|
|
Donor cause of death
Other
|
12 Participants
n=38 Participants
|
12 Participants
n=36 Participants
|
24 Participants
n=74 Participants
|
|
Type of preservation solution
HTK (Histidine-tryptophan-ketoglutarate)
|
6 Participants
n=38 Participants
|
5 Participants
n=36 Participants
|
11 Participants
n=74 Participants
|
|
Type of preservation solution
UW (University of Wisconsin)
|
7 Participants
n=38 Participants
|
5 Participants
n=36 Participants
|
12 Participants
n=74 Participants
|
|
Type of preservation solution
IGL-1 (Institut Georges Lopez-1)
|
25 Participants
n=38 Participants
|
25 Participants
n=36 Participants
|
50 Participants
n=74 Participants
|
|
Type of preservation solution
Other
|
0 Participants
n=38 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=74 Participants
|
|
Brain death duration
|
13.3 hours
n=26 Participants • The duration of brain death is only measured in Donation after Brain Death donors (see Donor type)
|
14.3 hours
n=23 Participants • The duration of brain death is only measured in Donation after Brain Death donors (see Donor type)
|
13.5 hours
n=49 Participants • The duration of brain death is only measured in Donation after Brain Death donors (see Donor type)
|
|
Donor hepatectomy duration
|
34.5 minutes
n=38 Participants
|
32.5 minutes
n=36 Participants
|
34 minutes
n=74 Participants
|
|
Cold ischemia time
|
5.8 hours
n=38 Participants
|
5.8 hours
n=36 Participants
|
5.8 hours
n=74 Participants
|
|
Model for End-Stage Liver Disease score (MELD)
|
13.2 score on a scale
n=38 Participants
|
13.8 score on a scale
n=36 Participants
|
13.6 score on a scale
n=74 Participants
|
|
Indication for liver transplant
Metabolic disease
|
4 participants
n=38 Participants
|
3 participants
n=36 Participants
|
7 participants
n=74 Participants
|
|
Indication for liver transplant
HCC
|
18 participants
n=38 Participants
|
12 participants
n=36 Participants
|
30 participants
n=74 Participants
|
|
Indication for liver transplant
Chronic liver disease
|
25 participants
n=38 Participants
|
18 participants
n=36 Participants
|
43 participants
n=74 Participants
|
|
Indication for liver transplant
Ethyl
|
23 participants
n=38 Participants
|
18 participants
n=36 Participants
|
41 participants
n=74 Participants
|
|
Indication for liver transplant
HBV
|
2 participants
n=38 Participants
|
0 participants
n=36 Participants
|
2 participants
n=74 Participants
|
|
Indication for liver transplant
HCV
|
2 participants
n=38 Participants
|
0 participants
n=36 Participants
|
2 participants
n=74 Participants
|
|
Indication for liver transplant
Cholestatic disease
|
4 participants
n=38 Participants
|
4 participants
n=36 Participants
|
8 participants
n=74 Participants
|
|
Indication for liver transplant
Nonalcoholic Steatohepatitis
|
2 participants
n=38 Participants
|
10 participants
n=36 Participants
|
12 participants
n=74 Participants
|
|
Indication for liver transplant
Cryptogenic
|
1 participants
n=38 Participants
|
0 participants
n=36 Participants
|
1 participants
n=74 Participants
|
|
Implantation duration
|
39.5 Minutes
n=38 Participants
|
38.5 Minutes
n=36 Participants
|
39.0 Minutes
n=74 Participants
|
PRIMARY outcome
Timeframe: within 72 hours following liver transplantationpeak AST is defined as the highest value of serum AST within 72 hours following liver transplantation
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Peak Aspartate Aminotransferase Within First 72h Post Transplant
|
1262.9 U/L
Interval 946.3 to 1685.4
|
1451.2 U/L
Interval 1087.4 to 1936.7
|
SECONDARY outcome
Timeframe: 3 and 12 months after liver transplantationPopulation: Death-censored graft survival
graft loss at 3 and 12 months after liver transplantation
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Graft Loss
3-months
|
2 Participants
|
0 Participants
|
|
Graft Loss
12-months
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 and 12 months after liver transplantationrecipient death at 3 and 12 months after liver transplantation
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Recipient Death
3 months
|
3 Participants
|
1 Participants
|
|
Recipient Death
12 months
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: within first 7 daysearly graft dysfunction as defined by Olthoff
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Early Graft Dysfunction
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: within 12 months post transplantationBiliary strictures are the narrowing of the intrahepatic or extrahepatic biliary ductal system. Here we report the number of participants developing biliary strictures within 12 months post transplantation by MRCP (magnetic resonance cholangiopancreatography)
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Number of Participants Developing Biliary Strictures
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: One hour post reperfusionIschemia Reperfusion Injury score 1h post reperfusion by using the Suzuki score and Monbaliu et al. The score ranges from 0 (no injury) to 4 (severe injury).
Outcome measures
| Measure |
Combined Drug Approach
n=25 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=23 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Ischemia Reperfusion Injury Score
|
2 score
Interval 2.0 to 4.0
|
2 score
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: till 1 year after transplantationa liver biopsy will be taken after transplantation and in case of clinical suspicion of acute rejection
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Graft Rejection
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: within 1 year after liver transplantationThe ranking of surgical complications will be done by using Clavien-Dindo classification Grade I Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (e.g. antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside Grade II Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III Complications requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complications; this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade V Death of the patient A severe surgical complication is defined as Grade III or higher.
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Patients With at Least 1 Severe Surgical Complications
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 yearNon-anastomotic biliary stricture at 1 year
Outcome measures
| Measure |
Combined Drug Approach
n=36 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Non-anastomotic Biliary Stricture
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 48hAn acute kidney injury score of 1 indicates risk; 2, injury; and 3, failure. According to RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) Minimum score is 0 meaning there is no injury, maximum score is 3 meaning failure of the organ.
Outcome measures
| Measure |
Combined Drug Approach
n=34 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=35 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Acute Kidney Injury Score
RIFLE 0
|
27 Participants
|
31 Participants
|
|
Acute Kidney Injury Score
RIFLE 1
|
4 Participants
|
1 Participants
|
|
Acute Kidney Injury Score
RIFLE 2
|
2 Participants
|
3 Participants
|
|
Acute Kidney Injury Score
RIFLE 3
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: first 5 minutes following graft reperfusionPost-reperfusion syndrome defined as a 30% decrease of mean systemic blood pressure for more than 1 minute during the first 5 minutes following graft reperfusion
Outcome measures
| Measure |
Combined Drug Approach
n=29 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=29 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Post-Reperfusion Syndrome
|
7 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospital stay for liver transplantationIntensive Care Unit stay immediately after liver transplantation (not after rehospitalization)
Outcome measures
| Measure |
Combined Drug Approach
n=38 Participants
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 Participants
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Intensive Care Unit Length of Stay (Recipient)
|
3 Days
Interval 1.5 to 6.5
|
4 Days
Interval 2.5 to 7.0
|
Adverse Events
Combined Drug Approach
Serious events: 6 serious events
Other events: 33 other events
Deaths: 4 deaths
Controles
Serious events: 4 serious events
Other events: 31 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Combined Drug Approach
n=36 participants at risk
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 participants at risk
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
Surgical and medical procedures
General surgical complications
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Renal and urinary disorders
Kidney dysfunction
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Infections and infestations
Bacterial infection
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Cardiac disorders
Arrythmia
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Surgical and medical procedures
Portal vein thrombosis
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
Other adverse events
| Measure |
Combined Drug Approach
n=36 participants at risk
the group receives a combination of drugs
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
|
Controles
n=36 participants at risk
the group do not receive a combination of drugs, but a placebo (sodium chloride solution)
Sodium chloride solution
|
|---|---|---|
|
General disorders
Post-operative delirium
|
25.0%
9/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
30.6%
11/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
12/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
25.0%
9/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure post-op
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
11.1%
4/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Renal and urinary disorders
Urinary tract infections
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
13.9%
5/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Endocrine disorders
De novo diabetes mellitus
|
8.3%
3/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Infections and infestations
Viral infections
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Infections and infestations
Bacterial infections
|
44.4%
16/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
27.8%
10/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Infections and infestations
Fungal infection
|
8.3%
3/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
8.3%
3/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Blood and lymphatic system disorders
Thrombo-embolitic complications
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Cardiac disorders
Cardiovascular events
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
General disorders
Cerebrovascular events
|
0.00%
0/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
2.8%
1/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Hepatobiliary disorders
Organ specific complications
|
13.9%
5/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Injury, poisoning and procedural complications
Surgical complications - arterial
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Injury, poisoning and procedural complications
Surgical complications portal
|
5.6%
2/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
8.3%
3/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Injury, poisoning and procedural complications
Surgical complications - general
|
61.1%
22/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
50.0%
18/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Hepatobiliary disorders
Biliary problems
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
13.9%
5/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
|
Immune system disorders
Rejections
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
16.7%
6/36 • Adverse events were collected over the time frame of 1 year starting immediately after transplantation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place