Heparin-Induced ThrombocytopeniaPhase 4NCT00603824
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
A Phase 4 study testing fondaparinux and argatroban or lepirudin in people with Heparin-Induced Thrombocytopenia, run by Methodist Healthcare - Memphis.
Trial summary
The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary… 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?
- fondaparinux and argatroban or lepirudin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jul 2010
- 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
- Male or female at least 18 years of age;
- If female of childbearing potential, negative pregnancy test result;
- Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
- Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).
Who cannot join
- Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
- Pregnancy or lactating;
- Blood dyscrasia other than HIT;
- History of thrombocytopenia associated with fondaparinux;
- Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
- Active bleeding of GI tract, GU tract, CNS or respiratory tract;
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- Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
- Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
- Hypersensitivity or contraindication to warfarin or fondaparinux.
About this study
Official title: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.
- Conditions
- Heparin-Induced Thrombocytopenia
- Being tested
- fondaparinux, argatroban or lepirudin
- Keywords
- heparin-Induced thrombocytopenia, fondaparinux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
Also called Arixtra
fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
argatroban or lepirudinDrug
Also called Refludan
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Fondaparinux Receives: Drug: fondaparinux |
| B | Active comparator | Direct thrombin inhibitor Receives: Drug: argatroban or lepirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count recovery
Measured: 5 days
Secondary outcomes (1)
Recurrent thromboembolic complications
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2010
Why it stopped: PI relocated
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Healthcare - Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Bob L Lobo, Pharm.D., Principal investigator, Methodist University HospitalSohail Minhas, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603824
- Sponsor's protocol ID
- MHIRB # 2007-058
- Status last verified
- Jun 2009
- First submitted
- 4 Jan 2008
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT00603824
- Acronym / sponsor ID
- MHIRB # 2007-058
- Conditions
- Heparin-Induced Thrombocytopenia
- Keywords
- heparin-Induced thrombocytopenia, fondaparinux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI relocated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Healthcare - MemphisUniversity, hospital or other
- Collaborators
- University of Tennessee
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jan 2008 (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 test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: fondaparinuxFondaparinux |
| B | Active comparator | Drug: argatroban or lepirudinDirect thrombin inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years of age;
- If female of childbearing potential, negative pregnancy test result;
- Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
- Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).
Key exclusion criteria (9 listed)
- Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
- Pregnancy or lactating;
- Blood dyscrasia other than HIT;
- History of thrombocytopenia associated with fondaparinux;
- Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
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 |
|---|---|---|
| fondaparinuxAlso: Arixtrafondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg | Drug | A |
| argatroban or lepirudinAlso: Refludancontinuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range | Drug | B |
Primary outcome
Platelet count recovery
Time frame: 5 days
1 secondary outcome
Recurrent thromboembolic complications
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
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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.
Bob L Lobo, Pharm.D. principal investigator
Methodist University Hospital
Sohail Minhas, MD principal investigator
University of Tennessee
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fondaparinux and argatroban or lepirudin in people with Heparin-Induced Thrombocytopenia, run by Methodist Healthcare - Memphis.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Platelet count recovery (time frame: 5 days). 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 13 Aug 2019.