Heparin-Induced ThrombocytopeniaPhase 2NCT00673439
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
A Phase 2 study testing fondaparinux and warfarin in people with Heparin-Induced Thrombocytopenia, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heparin-Induced Thrombocytopenia
- What is being tested?
- fondaparinux and warfarin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- high risk for HIT based on "Four Ts score" of 6 or more
Who cannot join
- pulmonary emboli at the time of enrollment
- arterial thrombosis at the time of enrollment
- limb threatening phlegmasia cerulea dolens at the time of enrollment
- Calculated Creatinin Clearance less than 50 ml/hr
- platelet count less than 50
- Weight less than 50 kg
Show all 12Show fewer
- pregnancy
- allergy to fondaparinux
- bacterial endocarditis
- history of neuraxial anesthesia and post-operative indwelling epidural catheter
- active major bleeding (hemodynamically significant or requiring transfusions)
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
Read the detailed description
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.
Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.
- Conditions
- Heparin-Induced Thrombocytopenia
- Being tested
- fondaparinux, warfarin
- Keywords
- heparin-induced thrombocytopenia, thrombocytopenia, HIT, thrombosis, blood clot, blood thinner, anticoagulant, heparin, warfarin, fondaparinux, Arixtra
- Medical subject headings
- Thrombocytopenia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
Also called Arixtra
Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2
warfarinDrug
Also called Coumadin
Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fondaparinux | Experimental | daily subcutaneous injection of fondaparinux (7.5-10 mg) Receives: Drug: fondaparinux; Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Showing Clinically Significant Bleeding
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Measured: 4 weeks after INR reaches 2 or more
Secondary outcomes (1)
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Measured: 4 weeks after INR reaches 2 or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: study terminated due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heparin-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Goetz Kloecker, University of Louisville
- Investigators
- Goetz H Kloecker, MD, MSPH, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673439
- Sponsor's protocol ID
- 07.0100
- Other IDs
- BCC-NON-07-001
- Status last verified
- Oct 2019
- First submitted
- 5 May 2008
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
- ClinicalTrials.gov ID
- NCT00673439
- Acronym / sponsor ID
- 07.0100
- Conditions
- Heparin-Induced Thrombocytopenia
- Keywords
- heparin-induced thrombocytopenia, thrombocytopenia, HIT, thrombosis, blood clot, blood thinner, anticoagulant, heparin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated due to low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Nov 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 24 Jun 2013
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 how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
Detailed description
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.
Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fondaparinux | Experimental | Drug: fondaparinux, Drug: warfarindaily subcutaneous injection of fondaparinux (7.5-10 mg) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high risk for HIT based on "Four Ts score" of 6 or more
Key exclusion criteria (12 listed)
- pulmonary emboli at the time of enrollment
- arterial thrombosis at the time of enrollment
- limb threatening phlegmasia cerulea dolens at the time of enrollment
- Calculated Creatinin Clearance less than 50 ml/hr
- platelet count less than 50
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: ArixtraDosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2 | Drug | Fondaparinux |
| warfarinAlso: CoumadinDosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks | Drug | Fondaparinux |
Primary outcome
Number of Participants Showing Clinically Significant Bleeding
Time frame: 4 weeks after INR reaches 2 or more
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
1 secondary outcome
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Time frame: 4 weeks after INR reaches 2 or more
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Goetz H Kloecker, MD, MSPH principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fondaparinux and warfarin in people with Heparin-Induced Thrombocytopenia, run by University of Louisville at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 8 Nov 2019. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Showing Clinically Significant Bleeding (time frame: 4 weeks after INR reaches 2 or more). 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 8 Nov 2019.