ComplicationNCT01711957
The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation
An observational study of Complication and Death, run by University of Zurich at 1 site in Switzerland.
Trial summary
Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication, Death
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage liver disease and/or primary liver tumor undergoing liver transplantation
Who may be able to join
- Age >18 years old
- End stage liver disease
- Cadaveric-donor liver transplantation
Who cannot join
- Age <18 years old
- Pregnancy
- Living-related liver transplantation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Visceral Surgery and Transplantation
Zurich, Canton of Zurich, 8091
About this study
Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy.
The investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.
- Conditions
- Complication, Death
- Being tested
- Liver transplantation
- Keywords
- Complications, Mortality, Liver transplantation, Platelet count, Survival
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Also called Orthotopic liver transplantation (OLT), Cadaveric-donor liver transplantation
Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society
| Study group | Role | What they receive |
|---|---|---|
| Liver disease and liver transplantation | Patient with end stage liver disease and/or primary liver tumor undergoing liver transplantation Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complication after liver transplantation
The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.
Measured: 90 days
Secondary outcomes (2)
Primary graft non-function
Defined as death or retransplantation within the first postoperative week after exclusion of technical, immunological, and infectious causes
Measured: first postoperative week
Delayed graft function
Defined as the presence of at least one of the following parameter at 7 days after LT: serum bilirubin > 10 mg/dL and International Normalized Ratio (INR) >1.6 or Alanine aminotransferase serum level (ALT) >2000UI/L
Measured: 7 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Aristotle Raptis, University of Zurich
- Investigators
- Mickael Lesurtel, M.D., PhD, Study director, University of ZurichPierre-Alain Clavien, M.D., PhD, Study chair, University of ZurichDimitri A. Raptis, M.D., MSc, Principal investigator, University of ZurichEmmanuel Melloul, M.D., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711957
- Sponsor's protocol ID
- EK-1487
- Status last verified
- Oct 2012
- First submitted
- 18 Oct 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lesurtel M, Raptis DA, Melloul E, Schlegel A, Oberkofler C, El-Badry AM, Weber A, Mueller N, Dutkowski P, Clavien PA. Low platelet counts after liver transplantation predict early posttransplant survival: the 60-5 criterion. Liver Transpl. 2014 Feb;20(2):147-55. doi: 10.1002/lt.23759. Epub 2013 Nov 21.
PubMed 24123804
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Value of Platelet Counts in Predicting Outcome After Liver Transplantation
- ClinicalTrials.gov ID
- NCT01711957
- Acronym / sponsor ID
- EK-1487
- Conditions
- Complication, Death
- Keywords
- Complications, Mortality, Liver transplantation, Platelet count, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent experimental and clinical studies have shown that platelets play a critical role in liver ischemia and regeneration. Thrombocytopenia, a frequent and potentially serious condition in liver transplantation (LT) recipients, was shown to be associated with postoperative morbidity and mortality after partial hepatectomy.
The investigators aim at evaluating whether postoperative low platelet counts are indicators of short- and long-term outcomes after liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver disease and liver transplantation | – | Procedure: Liver transplantationPatient with end stage liver disease and/or primary liver tumor undergoing liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage liver disease and/or primary liver tumor undergoing liver transplantation
Key inclusion criteria (3 listed)
- Age >18 years old
- End stage liver disease
- Cadaveric-donor liver transplantation
Key exclusion criteria (3 listed)
- Age <18 years old
- Pregnancy
- Living-related liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver transplantationAlso: Orthotopic liver transplantation (OLT), Cadaveric-donor liver transplantationStandardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society | Procedure or surgery | Liver disease and liver transplantation |
Primary outcome
Severe complication after liver transplantation
Time frame: 90 days
The severity of complications will be graded according to the Clavien-Dindo classification by outcome. Grade III to V complications will be considered as severe.
2 secondary outcomes
Primary graft non-function
Time frame: first postoperative week
Delayed graft function
Time frame: 7 days after liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Derived from this study: PubMed 24123804Lesurtel M, Raptis DA, Melloul E, Schlegel A, Oberkofler C, El-Badry AM, Weber A, Mueller N, Dutkowski P, Clavien PA. Low platelet counts after liver transplantation predict early posttransplant survival: the 60-5 criterion. Liver Transpl. 2014 Feb;20(2):147-55. doi: 10.1002/lt.23759. Epub 2013 Nov 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mickael Lesurtel, M.D., PhD study director
University of Zurich
Pierre-Alain Clavien, M.D., PhD study chair
University of Zurich
Dimitri A. Raptis, M.D., MSc principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication and Death, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complication after liver transplantation (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.