Heparin-Induced ThrombocytopeniaNCT03269019
Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
An observational study of Heparin-Induced Thrombocytopenia and Thrombosis, run by Wuhan Asia Heart Hospital.
Trial summary
Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia, Thrombosis, Biomarkers
- What is being tested?
- HIT with thrombosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2017to 31 Dec 2019
- 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 are those who receiving cardiac surgery, including valve replacementheart,Coronary Artery Bypass Grafting,aorta replacement etc.
Who may be able to join
- Hospitalized patients undergoing cardiac surgery.
- Receiving unfractionated heparin anticoagulation.
Who cannot join
- history of heparin-induced thrombocytopenia
- pregnant woman
Trial locations and contacts
No sites are listed yet.
About this study
Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important.
This study is planned to assess the use of thrombotic biomarkers in patients with HIT, including thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and clinical outcomes, including new thrombus and death, were recorded during follow-up.
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis, Biomarkers
- Being tested
- HIT with thrombosis
- Keywords
- Heparin-induced thrombocytopenia, Thrombosis, thrombin-antithrombin, d-dimer, Thrombelastograghy
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIT with thrombosisDiagnostic test
Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.
| Study group | Role | What they receive |
|---|---|---|
| HIT-group | The patients with heparin-induced thrombocytopenia. Receives: Diagnostic Test: HIT with thrombosis | |
| HITTs-group | The patients with heparin-induced thrombocytopenia with thrombosis. Receives: Diagnostic Test: HIT with thrombosis | |
| Control group | The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic event
New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
Measured: 30 days
Deaths
All-cause deaths
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start20 Nov 2017 (estimated)
- Primary completion19 Aug 2019 (estimated)
- Study completion31 Dec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenlu Zhang, MD,Ph.D, Study director, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269019
- Sponsor's protocol ID
- 2017CX05
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are going to make individual participant data (IPD) available to other researchers after our paper published.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03269019
- Acronym / sponsor ID
- 2017CX05
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis, Biomarkers
- Keywords
- Heparin-induced thrombocytopenia, Thrombosis, thrombin-antithrombin, d-dimer, Thrombelastograghy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 20 Nov 2017 (estimated)
- Primary completion
- 19 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Aug 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.
Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important.
This study is planned to assess the use of thrombotic biomarkers in patients with HIT, including thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and clinical outcomes, including new thrombus and death, were recorded during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIT-group | – | Diagnostic Test: HIT with thrombosisThe patients with heparin-induced thrombocytopenia. |
| HITTs-group | – | Diagnostic Test: HIT with thrombosisThe patients with heparin-induced thrombocytopenia with thrombosis. |
| Control group | – | –The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are those who receiving cardiac surgery, including valve replacementheart,Coronary Artery Bypass Grafting,aorta replacement etc.
Key inclusion criteria (2 listed)
- Hospitalized patients undergoing cardiac surgery.
- Receiving unfractionated heparin anticoagulation.
Key exclusion criteria (2 listed)
- history of heparin-induced thrombocytopenia
- pregnant woman
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 |
|---|---|---|
| HIT with thrombosisTesting thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy. | Diagnostic test | HIT-group, HITTs-group |
Primary outcome
Thrombotic event
Time frame: 30 days
New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
Deaths
Time frame: 30 days
All-cause deaths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: Undecided. We are going to make individual participant data (IPD) available to other researchers after our paper published.
Related trials for Heparin-Induced Thrombocytopenia
Not yet recruitingObservational study
Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
Heparin-induced Thrombocytopenia
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.
Zhenlu Zhang, MD,Ph.D study director
Wuhan Asia Heart Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-Induced Thrombocytopenia and Thrombosis, run by Wuhan Asia Heart Hospital.
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 2 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 31 Aug 2017. 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.
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 Qingkun Fan, MD (+86 027 65796747, fqk@wahh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic event (time frame: 30 days). The study lists 2 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 31 Aug 2017.