Heparin-induced ThrombocytopeniaPhase 3HITNCT03147638
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
A Phase 3 study testing Warfarin, NOAC in people with Heparin-induced Thrombocytopenia, run by Marshall University at 1 site in United States.
Trial summary
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT) Read more about this study
- Who is it for?
- Ages 18 to 97 years
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- What is being tested?
- Warfarin, NOAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2017to 30 Jun 2019
- Phase
- Phase 3
- 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 97 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be able to provide an informed consent
- Patient older than 18 years' old
- Patient with suspected diagnosis of HIT, need 2 of the following:
- have a fall in platelet count of > 30% from a baseline prior to heparin/LMWH Platelet factor 4 (PF4) ELISA positive Develop skin lesions secondary to subcutaneous heparin With T score more than 4 For those less than 4 we will use serotonin release assay-SRA
- Patient received the bridging therapy of non-heparin anticoagulant
- Patient is receiving the standard of care treatment for HIT
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- Patient is willing to be followed up for by one of the physicians listed in the delegation log
- The Primary physician responsible for the patient is agreeing for the patient to participate
- Patients are not involved in a clinical trial for HIT management
Who cannot join
- Patient is unable to sign an informed consent
- Patient doesn't have a confirmed diagnosis of HIT
- Patient Does not have Pulmonary embolus
- Patient does is not on Warfarin for other indications
- Patient is a known case of hypercoagulable disorder
- Patient is not willing to come back for follow up
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- Patient is critically ill or has a life expectancy of less than 3 months
- Pregnancy that is in First trimester.
- Multi-system organ failure or estimated survival of less than 30 days
- Uncontrolled hypertension defined as a blood pressure >180/110 mm Hg
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marshall University
Huntington, West Virginia, 25701
Yazan Numan, M.D., 304-591-0000, numan@marshall.edu
About this study
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
- Conditions
- Heparin-induced Thrombocytopenia
- Being tested
- Warfarin, NOAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin, NOACDrug
duration of treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 month | Experimental | patient treated with Anti coagulation for one month Receives: Drug: Warfarin, NOAC |
| 3 months | Active comparator | standard of care , treatment for 3 months Receives: Drug: Warfarin, NOAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause hospitalization
Measured: Within six months after treatment
side effects of Warfarin treatment
Measured: Within six months after treatment
All cause mortality
Measured: Within six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start11 Jan 2017
- Primary completion11 Jan 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single arm with retrospective arm The retrospective arm is he comparator and they are historic control
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yazan Numan, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147638
- Sponsor's protocol ID
- 943871-5
- Acronym
- HIT
- Status last verified
- Aug 2018
- First submitted
- 1 May 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
- ClinicalTrials.gov ID
- NCT03147638
- Acronym / sponsor ID
- HIT / 943871-5
- Conditions
- Heparin-induced Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 11 Jan 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single arm with retrospective arm The retrospective arm is he comparator and they are historic control
| Arm | Type | Receives |
|---|---|---|
| 1 month | Experimental | Drug: Warfarin, NOACpatient treated with Anti coagulation for one month |
| 3 months | Active comparator | Drug: Warfarin, NOACstandard of care , treatment for 3 months |
Who may qualify
- Ages
- 18 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be able to provide an informed consent
- Patient older than 18 years' old
- Patient with suspected diagnosis of HIT, need 2 of the following:
- have a fall in platelet count of > 30% from a baseline prior to heparin/LMWH Platelet factor 4 (PF4) ELISA positive Develop skin lesions secondary to subcutaneous heparin With T score more than 4 For those less than 4 we will use serotonin release assay-SRA
- Patient received the bridging therapy of non-heparin anticoagulant
Key exclusion criteria (10 listed)
- Patient is unable to sign an informed consent
- Patient doesn't have a confirmed diagnosis of HIT
- Patient Does not have Pulmonary embolus
- Patient does is not on Warfarin for other indications
- Patient is a known case of hypercoagulable disorder
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 |
|---|---|---|
| Warfarin, NOACduration of treatment | Drug | 1 month, 3 months |
Primary outcome
All cause hospitalization
Time frame: Within six months after treatment
side effects of Warfarin treatment
Time frame: Within six months after treatment
All cause mortality
Time frame: Within six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Warfarin, NOAC in people with Heparin-induced Thrombocytopenia, run by Marshall University 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 9 inclusion and 10 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 Aug 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Yazan Numan, M.D. (3045910000, numan@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause hospitalization (time frame: Within six months after treatment). The study lists 3 primary outcomes in all. 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 15 Aug 2018.