Heparin-induced ThrombocytopeniaHITOLTNCT01654848
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients
An observational study of Heparin-induced Thrombocytopenia and Liver Transplantation, run by CHIR-Net at 1 site in Germany.
Trial summary
In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heparin-induced Thrombocytopenia, Liver Transplantation
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Aug 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive livertransplant recipients of our transplant center, organ allocation via Eurotransplant Foundation, Leiden, The Netherlands; Laboratory investigations performed at the Abteilung für Transfusionsmedizin am Institut für Immunologie und Transfusionsmedizin der Universitätsmedizin Greifswald, Greifswald, Germany
Who may be able to join
- all consecutive liver transplant recipients between 01/2010 and 08/2011 who
- were transplanted at our center after allocation of a liver graft via Eurotransplant
Who cannot join
- patient's refusal to participate in prospective observation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients: a Prospective Multivariate Analysis of Prognostic Factors and Haemostaseological Findings
In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated.
Read the detailed description
The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and their functional activity (HIPA) in 38 whole organ deceased donor liver transplant recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and laboratory findings (ALAT, ASAT, cholinesterase) were investigated.
- Keywords
- liver transplantation, thrombocytes, heparin-induced thrombocytopenia, multivariate analysis of associated factors of HIT 2 after OLT, laboratory investigations of HIT-antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| orthotopic Liver Transplantation | consecutive inclusion of all recipients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced ThrombocytopeniaStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHIR-Net
- Sponsor type
- Research network
- Collaborators
- University Medicine Greifswald
- Responsible party
- Sponsor
- Investigators
- Volker Assfalg, MD, Principal investigator, Klinikum rechts der Isar, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654848
- Sponsor's protocol ID
- TransplanTUM-1
- Other IDs
- HITafterOLT
- Acronym
- HITOLT
- Status last verified
- Jul 2012
- First submitted
- 30 Mar 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients: a Prospective Multivariate Analysis of Prognostic Factors and Haemostaseological Findings
- ClinicalTrials.gov ID
- NCT01654848
- Acronym / sponsor ID
- HITOLT / TransplanTUM-1
- Keywords
- liver transplantation, thrombocytes, heparin-induced thrombocytopenia, multivariate analysis of associated factors of HIT 2 after OLT, laboratory investigations of HIT-antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CHIR-NetResearch network
- Collaborators
- University Medicine Greifswald
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Aug 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.
In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated.
Detailed description
The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and their functional activity (HIPA) in 38 whole organ deceased donor liver transplant recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and laboratory findings (ALAT, ASAT, cholinesterase) were investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orthotopic Liver Transplantation | – | –consecutive inclusion of all recipients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive livertransplant recipients of our transplant center, organ allocation via Eurotransplant Foundation, Leiden, The Netherlands; Laboratory investigations performed at the Abteilung für Transfusionsmedizin am Institut für Immunologie und Transfusionsmedizin der Universitätsmedizin Greifswald, Greifswald, Germany
Key inclusion criteria (2 listed)
- all consecutive liver transplant recipients between 01/2010 and 08/2011 who
- were transplanted at our center after allocation of a liver graft via Eurotransplant
Key exclusion criteria (1 listed)
- patient's refusal to participate in prospective observation
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 1 Aug 2012.
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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.
Volker Assfalg, MD principal investigator
Klinikum rechts der Isar, Dept. of Surgery
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 Heparin-induced Thrombocytopenia and Liver Transplantation, run by CHIR-Net 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 1 Aug 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 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?
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 1 Aug 2012.