Heparin-Induced ThrombocytopeniaPhase 4NCT00196417
The HIT-TRAP Trial
A Phase 4 study testing Standard heparin (UFH) versus certoparin (LMWH) in people with Heparin-Induced Thrombocytopenia, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia
- What is being tested?
- Standard heparin (UFH) versus certoparin (LMWH)
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Nov 2005
- Phase
- Phase 4
- 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
Who may be able to join
- trauma-surgical patient
- consent given
- minimum age 18
- expected inpatient period at least 7 days
- need for thrombosis prophylaxis with heparin
Who cannot join
- intolerance of one of the study drugs
- malignancy with life expectancy < 3 months
- pregnancy/lactation
- drug or alcohol abuse
- fibrinolytic therapy
- need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry
- participation in another clinical trial within 30 days prior to intended inclusion
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery
Greifswald, 17489
About this study
Official title: Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial
Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).
Read the detailed description
This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH).
Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT).
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge.
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.
- Conditions
- Heparin-Induced Thrombocytopenia
- Being tested
- Standard heparin (UFH) versus certoparin (LMWH)
- Keywords
- heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard heparin (UFH) versus certoparin (LMWH)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
Secondary outcomes (2)
Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Study completionNov 2005
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Andreas Greinacher, Prof. Dr., Principal investigator, Ernst-Moritz-Arndt University Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196417
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial
- ClinicalTrials.gov ID
- NCT00196417
- Acronym / sponsor ID
- 001
- Conditions
- Heparin-Induced Thrombocytopenia
- Keywords
- heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2003
- Study completion
- Nov 2005
- First posted
- 20 Sep 2005 (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.
Randomised, double blind trial in non-intensive care trauma patients comparing unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH) in heparin-induced thrombocytopenia (HIT).
Detailed description
This is a randomised, double blind trial including trauma patients with need for thrombosis prophylaxis with heparin. Patients receive either unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH).
Heparin-induced thrombocytopenia (HIT) antibodies are measured on days 1 and 10. There are daily platelet counts. On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis (DVT).
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge.
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies, and if yes, whether these differences lead to different clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- trauma-surgical patient
- consent given
- minimum age 18
- expected inpatient period at least 7 days
- need for thrombosis prophylaxis with heparin
Key exclusion criteria (7 listed)
- intolerance of one of the study drugs
- malignancy with life expectancy < 3 months
- pregnancy/lactation
- drug or alcohol abuse
- fibrinolytic therapy
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 |
|---|---|---|
| Standard heparin (UFH) versus certoparin (LMWH) | Drug | – |
Primary outcome
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients
2 secondary outcomes
Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status
TECs during 3 months following discharge in relation to heparin received and HIT-antibody status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Recruiting
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Heparin-induced Thrombocytopenia, HIT
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.
Andreas Greinacher, Prof. Dr. principal investigator
Ernst-Moritz-Arndt University Greifswald, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard heparin (UFH) versus certoparin (LMWH) in people with Heparin-Induced Thrombocytopenia, run by University Medicine Greifswald 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 5 inclusion and 7 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 20 Sep 2005. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients. It is what the study was designed to measure, not a finding.
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 20 Sep 2005.