Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

August 30, 2017 updated by: Wuhan Asia Heart Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are those who receiving cardiac surgery, including valve replacementheart,Coronary Artery Bypass Grafting,aorta replacement etc.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • history of heparin-induced thrombocytopenia
  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIT-group
The patients with heparin-induced thrombocytopenia.
Diagnostic test: HIT with thrombosis
Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.
HITTs-group
The patients with heparin-induced thrombocytopenia with thrombosis.
Diagnostic test: HIT with thrombosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombotic event
Time Frame: 30 days
New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.
30 days
Deaths
Time Frame: 30 days
All-cause deaths
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Asia Heart Hospital

Investigators

  • Study Director: Zhenlu Zhang, MD,Ph.D, Wuhan Asia Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 20, 2017

Primary Completion (Anticipated)

August 19, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017CX05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We are going to make individual participant data (IPD) available to other researchers after our paper published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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