Contact information
Type
Scientific
Primary contact
Prof Wang Yongjun
ORCID ID
Contact details
Tiantan Hospital
Beijing
100050
China
+86 (0)10 6701 3383
zhg_doc@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INVENT-10
Study information
Scientific title
Acronym
INVENT-China
Study hypothesis
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
Ethics approval
Approval received from the Tiantan Hospital Ethics Committee on the 29th November 2006 (ref: 7).
Study design
Multicentre observational, prospective, nested case-control study.
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Venous thromboembolism
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Incidence of Deep Venous Thrombosis after acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.
Secondary outcome measures
Predict model of VTE in acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.
Overall trial start date
08/05/2007
Overall trial end date
08/10/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1882
Participant exclusion criteria
1. Transient Ischaemic Attacks (TIAs)
2. Sub-Arachnoid Haemorrhage (SAH)
3. Tumour
4. Medical history of VTE
Recruitment start date
08/05/2007
Recruitment end date
08/10/2007
Locations
Countries of recruitment
China
Trial participating centre
Tiantan Hospital
Beijing
100050
China
Funders
Funder type
Industry
Funder name
Glaxosmithkline (China)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Beijing Municiple Science and Technology Commission (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary