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Status unknownNCT03269019Updated Aug 31, 2017

Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia

An observational study in Heparin-Induced Thrombocytopenia, Thrombosis and Biomarkers, sponsored by Wuhan Asia Heart Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-31.

Sponsored by Wuhan Asia Heart Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heparin-Induced Thrombocytopenia
  • Thrombosis
  • Biomarkers

Keywords

  • Heparin-induced thrombocytopenia
  • Thrombosis
  • thrombin-antithrombin
  • d-dimer
  • Thrombelastograghy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of heparin-induced thrombocytopenia
  • pregnant woman
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • HIT-group

    The patients with heparin-induced thrombocytopenia.

    Diagnostic Test: HIT with thrombosis

  • HITTs-group

    The patients with heparin-induced thrombocytopenia with thrombosis.

    Diagnostic Test: HIT with thrombosis

  • Control group

    The patients without heparin-induced thrombocytopenia and heparin-induced thrombocytopenia with thrombosis.

Interventions

  • Diagnostic testHIT with thrombosis

    Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.

05

What researchers measure

Primary outcomes

  1. Thrombotic event

    New thrombosis, including deep venous thrombosis,pulmonary embolism,Cerebral infarction,superior mesenteric artery embolism,artery embolism etc.

    Time frame: 30 days

  2. Deaths

    All-cause deaths

    Time frame: 30 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided — We are going to make individual participant data (IPD) available to other researchers after our paper published.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03269019
Lead sponsor
Wuhan Asia Heart Hospital
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Nov 20, 2017 (estimated)
Primary completion
Aug 19, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Aug 31, 2017

Study contacts

Qingkun Fan, MD
Contact
fqk@wahh.com.cn
+86 027 65796747
Zhenlu Zhang, MD,Ph.D
study director · Wuhan Asia Heart Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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