Liver TransplantationNCT00408889
Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation
An observational study of Liver Transplantation, run by Heidelberg University at 1 site in Germany.
Trial summary
Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver transplantation
Who may be able to join
- orthotopic liver transplantation
- age > 18 years
Who cannot join
- allergy to indocyangreen
Trial locations and contacts
1 site in 1 country.
About this study
Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure.
Read the detailed description
Patients will be monitored 7 days following liver transplantation, including clinical scores, clinical chemistry, ultrasound findings and indocyaninegreen-clearance.
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, organ failure, outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startDec 2006
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 Liver TransplantationStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Eisenbach, Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408889
- Sponsor's protocol ID
- post OLT
- Status last verified
- Dec 2008
- First submitted
- 6 Dec 2006
- Last updated
- 9 Apr 2010
- Results posted
- No
Publications
Schneider L, Spiegel M, Latanowicz S, Weigand MA, Schmidt J, Werner J, Stremmel W, Eisenbach C. Noninvasive indocyanine green plasma disappearance rate predicts early complications, graft failure or death after liver transplantation. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):362-8. doi: 10.1016/s1499-3872(11)60061-1.
PubMed 21813383
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation
- ClinicalTrials.gov ID
- NCT00408889
- Acronym / sponsor ID
- post OLT
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, organ failure, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Dec 2006
- First posted
- 7 Dec 2006 (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.
Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure.
Detailed description
Patients will be monitored 7 days following liver transplantation, including clinical scores, clinical chemistry, ultrasound findings and indocyaninegreen-clearance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation
Key inclusion criteria (2 listed)
- orthotopic liver transplantation
- age > 18 years
Key exclusion criteria (1 listed)
- allergy to indocyangreen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
- Derived from this study: PubMed 21813383Schneider L, Spiegel M, Latanowicz S, Weigand MA, Schmidt J, Werner J, Stremmel W, Eisenbach C. Noninvasive indocyanine green plasma disappearance rate predicts early complications, graft failure or death after liver transplantation. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):362-8. doi: 10.1016/s1499-3872(11)60061-1.
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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.
Christoph Eisenbach, Dr. principal investigator
Heidelberg University
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 Liver Transplantation, run by Heidelberg University at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2010. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408889, 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 9 Apr 2010.