Heparin-Induced ThrombocytopeniaNCT01102790
Generation of Heparin-induced Thrombocytopenia (HIT)-Antibodies Without Prior Heparin Exposure
An observational study of Heparin-Induced Thrombocytopenia and Thrombosis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia, Thrombosis
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Oct 2010
- 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 in a primary care clinic undergoing orthopedic surgery without heparin exposure
Who may be able to join
- Major orthopedic surgery
Who cannot join
- Heparin exposure
- Infection
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
J.W.Goethe University Hospital Frankfurt/M.
Frankfurt am Main, Hesse, 60590
Marc Schindewolf, MD, +49 (0)69-6301 ext. 5096, marcschindewolf@yahoo.com
Edelgard Lindhoff-Last, Prof., +49 (0)69-6301 ext. 5096, Lindhoff-Last@em.uni-frankfurt.de
About this study
Official title: Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis
- Keywords
- HIT
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of HIT-antibodies
Measured: between day 5 and day 14 after surgery
Secondary outcomes (1)
thromboembolic events
Measured: up to 21 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marc Schindewolf, MD, Principal investigator, J.W. Goethe University-Hospital Frankfurt/M.Edelgard Lindhoff-Last, Prof., Principal investigator, J.W. Goethe-University Hospital Frankfurt/M.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102790
- Sponsor's protocol ID
- 243/09
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2010
- Last updated
- 15 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schindewolf M, Lindhoff-Last E. Fondaparinux-related thrombocytopenia in a patient with former HIT. Response to Rota et al. (Thromb Haemost 2008; 99: 779-781). Thromb Haemost. 2008 Jul;100(1):168-9; author reply 169-70. doi: 10.1160/TH08-04-0222. No abstract available.
PubMed 18612559Warkentin TE, Makris M, Jay RM, Kelton JG. A spontaneous prothrombotic disorder resembling heparin-induced thrombocytopenia. Am J Med. 2008 Jul;121(7):632-6. doi: 10.1016/j.amjmed.2008.03.012.
PubMed 18589060Jay RM, Warkentin TE. Fatal heparin-induced thrombocytopenia (HIT) during warfarin thromboprophylaxis following orthopedic surgery: another example of 'spontaneous' HIT? J Thromb Haemost. 2008 Sep;6(9):1598-600. doi: 10.1111/j.1538-7836.2008.03040.x. Epub 2008 May 29. No abstract available.
PubMed 18513213
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of HIT-antibodies Without Prior Heparin Exposure Following Orthopedic Surgery (Subgroup Study) (Change of Coagulation Parameters Under Exposition With New Anticoagulants [Title of the Main Study])
- ClinicalTrials.gov ID
- NCT01102790
- Acronym / sponsor ID
- 243/09
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis
- Keywords
- HIT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 13 Apr 2010 (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.
The purpose of this study is to determine the HIT-antibody generation without prior heparin-exposure in patients undergoing orthopedic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a primary care clinic undergoing orthopedic surgery without heparin exposure
Key inclusion criteria (1 listed)
- Major orthopedic surgery
Key exclusion criteria (2 listed)
- Heparin exposure
- Infection
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
incidence of HIT-antibodies
Time frame: between day 5 and day 14 after surgery
1 secondary outcome
thromboembolic events
Time frame: up to 21 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
- Background: PubMed 18612559Schindewolf M, Lindhoff-Last E. Fondaparinux-related thrombocytopenia in a patient with former HIT. Response to Rota et al. (Thromb Haemost 2008; 99: 779-781). Thromb Haemost. 2008 Jul;100(1):168-9; author reply 169-70. doi: 10.1160/TH08-04-0222. No abstract available.
- Background: PubMed 18589060Warkentin TE, Makris M, Jay RM, Kelton JG. A spontaneous prothrombotic disorder resembling heparin-induced thrombocytopenia. Am J Med. 2008 Jul;121(7):632-6. doi: 10.1016/j.amjmed.2008.03.012.
- Background: PubMed 18513213Jay RM, Warkentin TE. Fatal heparin-induced thrombocytopenia (HIT) during warfarin thromboprophylaxis following orthopedic surgery: another example of 'spontaneous' HIT? J Thromb Haemost. 2008 Sep;6(9):1598-600. doi: 10.1111/j.1538-7836.2008.03040.x. Epub 2008 May 29. No abstract available.
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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.
Marc Schindewolf, MD principal investigator
J.W. Goethe University-Hospital Frankfurt/M.
Edelgard Lindhoff-Last, Prof. principal investigator
J.W. Goethe-University Hospital Frankfurt/M.
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 Thrombosis, run by Johann Wolfgang Goethe University Hospital 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 1 inclusion and 2 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 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Schindewolf, MD (+49 (0)69-6301 ext. 5096, marcschindewolf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of HIT-antibodies (time frame: between day 5 and day 14 after surgery). 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 NCT01102790, which also lists 3 linked publications.
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 15 Apr 2010.