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ISRCTN
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ISRCTN34425939
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ClinicalTrials.gov identifier
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Public title
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INcidence of VENous Thromboembolism after acute stroke in China
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Scientific title
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Acronym
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INVENT-China
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Serial number at source
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INVENT-10
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Study hypothesis
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1. Incidence of venous thromboembolism after acute stroke in China was lower than in western countries
2. Risk factors are different between Venous Thromboembolism (VTE) and non-VTE
3. Anticoagulation and neurological rehabilation can reduce the incidence
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Lay summary
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Ethics approval
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Approval received from the Tiantan Hospital Ethics Committee on the 29th November 2006 (ref: 7).
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Study design
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Multicentre observational, prospective, nested case-control study.
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Countries of recruitment
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China
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Disease/condition/study domain
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Venous thromboembolism
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Participants - inclusion criteria
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1. Older than 18
2. Acute stroke patients within seven days
3. Identified by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. National Institutes of Health Stroke Scale (NIHSS) item-six more than one
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Participants - exclusion criteria
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1. Transient Ischaemic Attacks (TIAs)
2. Sub-Arachnoid Haemorrhage (SAH)
3. Tumour
4. Medical history of VTE
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Anticipated start date
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08/05/2007
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Anticipated end date
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08/10/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1882
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Interventions
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Group A: stroke inpatients with Deep Venous Thrombosis (DVT) during follow up
Group B: stroke inpatients without DVT during follow up
DVT will be determined by complete-comprehensive ultrasound sonography two weeks (14 ± 3 days) after stroke onset.
Possible risk factors will be compared between group A and group B, these will include:
1. stroke subtype
2. NIHSS
3. Medical history
4. Complications
5. High Density Lipoprotein (HDL)
6. Low Density Lipoprotein (LDL)
7. Triglycerides (TG)
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Primary outcome measure(s)
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Incidence of Deep Venous Thrombosis after acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.
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Secondary outcome measure(s)
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Predict model of VTE in acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.
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Sources of funding
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1. Glaxosmithkline (China)
2. Beijing Municiple Science and Technology Commission (China)
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Trial website
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Publications
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Contact name
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Prof
Wang
Yongjun
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Address
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Tiantan Hospital
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Tel
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+86 (0)10 6701 3383
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Fax
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+86 (0)10 6701 3383
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Email
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zhg_doc@yahoo.com
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Sponsor
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Beijing Tiantan Hospital (China)
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Address
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c/o Professor Yongjun Wang
Affiliated Hospital of Capital Medical University
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Date applied
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28/04/2007
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Last edited
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06/06/2007
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Date ISRCTN assigned
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06/06/2007
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