Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

• Conditions: Heparin-Induced Thrombocytopenia; Thrombosis; Biomarkers
• Interventions: Diagnostic Test: HIT with thrombosis

• Registration Number: NCT03269019
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Last Update Submitted: 2017-08-30
• Study First Posted: 2017-08-31
• Last Update Posted: 2017-08-31
• Study Start: 2017-11-20
• Primary Completion: 2019-08-19
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• history of heparin-induced thrombocytopenia
• pregnant woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIT-group	HIT with thrombosis	The patients with heparin-induced thrombocytopenia.
HITTs-group	HIT with thrombosis	The patients with heparin-induced thrombocytopenia with thrombosis.

Primary Outcome Measures

Name	Time	Method
Deaths	30 days	All-cause deaths
Thrombotic event	30 days	New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.