Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedAugust 31, 2017
August 1, 2017
1.7 years
August 30, 2017
August 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Thrombotic event
New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
30 days
Deaths
All-cause deaths
30 days
Study Arms (3)
HIT-group
The patients with heparin-induced thrombocytopenia.
HITTs-group
The patients with heparin-induced thrombocytopenia with thrombosis.
Control group
The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.
Interventions
Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.
Eligibility Criteria
Patients are those who receiving cardiac surgery, including valve replacementheart,Coronary Artery Bypass Grafting,aorta replacement etc.
You may qualify if:
- Hospitalized patients undergoing cardiac surgery.
- Receiving unfractionated heparin anticoagulation.
You may not qualify if:
- history of heparin-induced thrombocytopenia
- pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhenlu Zhang, MD,Ph.D
Wuhan Asia Heart Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
August 31, 2017
Study Start
November 20, 2017
Primary Completion
August 19, 2019
Study Completion
December 31, 2019
Last Updated
August 31, 2017
Record last verified: 2017-08