Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

Thrombosis Clinical Trial

Official title:

Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03269019
• Other study ID #: 2017CX05
• Status: Not yet recruiting
• Phase: N/A
• First received: August 30, 2017
• Last updated: August 30, 2017
• Start date: November 20, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: Wuhan Asia Heart Hospital
• Contact: Qingkun Fan, MD
• Phone: +86 027 65796747
• Email: fqk[@]wahh.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized patients undergoing cardiac surgery.

• Receiving unfractionated heparin anticoagulation.

Exclusion Criteria:

• history of heparin-induced thrombocytopenia

• pregnant woman

Related Conditions & MeSH terms

• Biomarkers
• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombosis

Intervention

Diagnostic Test:
• HIT with thrombosis
Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Asia Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombotic event	New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.	30 days
Primary	Deaths	All-cause deaths	30 days