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Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

NCT ID: NCT03269019

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heparin-Induced Thrombocytopenia Thrombosis Biomarkers

Keywords

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Heparin-induced thrombocytopenia Thrombosis thrombin-antithrombin d-dimer Thrombelastograghy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIT-group

The patients with heparin-induced thrombocytopenia.

HIT with thrombosis

Intervention Type DIAGNOSTIC_TEST

Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

HITTs-group

The patients with heparin-induced thrombocytopenia with thrombosis.

HIT with thrombosis

Intervention Type DIAGNOSTIC_TEST

Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

Control group

The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.

No interventions assigned to this group

Interventions

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HIT with thrombosis

Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients undergoing cardiac surgery.
* Receiving unfractionated heparin anticoagulation.

Exclusion Criteria

* history of heparin-induced thrombocytopenia
* pregnant woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenlu Zhang, MD,Ph.D

Role: STUDY_DIRECTOR

Wuhan Asia Heart Hospital

Central Contacts

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Qingkun Fan, MD

Role: CONTACT

Phone: +86 027 65796747

Email: [email protected]

Other Identifiers

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2017CX05

Identifier Type: -

Identifier Source: org_study_id