Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

NCT03269019 — Unknown, 200 participants, Wuhan Asia Heart Hospital
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RegistryNCT03269019
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorWuhan Asia Heart Hospital (Other)
ConditionsHeparin-Induced Thrombocytopenia, Thrombosis, Biomarkers
InterventionsHIT with thrombosis (Diagnostic test)
Datesstart 2017-11-20 (estimated), primary completion 2019-08-19 (estimated), completion 2019-12-31 (estimated), first posted 2017-08-31, last updated 2017-08-31

Related Papers Related Patents Related Grants Related Experts
All trials for Heparin-Induced Thrombocytopenia All trials for Thrombosis All trials of HIT with thrombosis

-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.

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.

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+Arms and interventions

ArmTypeInterventionsDescription
HIT-groupDiagnostic Test: HIT with thrombosisThe patients with heparin-induced thrombocytopenia.
HITTs-groupDiagnostic Test: HIT with thrombosisThe patients with heparin-induced thrombocytopenia with thrombosis.
Control groupThe patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.
  • HIT with thrombosis (Diagnostic test): Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

+Outcome measures

Primary outcomes

  • Thrombotic event [30 days]: New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
  • Deaths [30 days]: All-cause deaths

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* history of heparin-induced thrombocytopenia
* pregnant woman

+Investigators