ISRCTN ISRCTN34425939
DOI https://doi.org/10.1186/ISRCTN34425939
Protocol serial number INVENT-10
Sponsor Beijing Tiantan Hospital (China)
Funders Glaxosmithkline (China), Beijing Municiple Science and Technology Commission (China)
Submission date
28/04/2007
Registration date
06/06/2007
Last edited
19/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wang Yongjun
Scientific

Tiantan Hospital
Beijing
100050
China

Phone +86 (0)10 6701 3383
Email zhg_doc@yahoo.com

Study information

Primary study designObservational
Study designMulticentre observational, prospective, nested case-control study.
Secondary study designCase-control study
Scientific titleINcidence of VENous Thromboembolism after acute stroke in China
Study acronymINVENT-China
Study objectives1. 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(s)Approval received from the Tiantan Hospital Ethics Committee on the 29th November 2006 (ref: 7).
Health condition(s) or problem(s) studiedVenous thromboembolism
InterventionGroup 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 typeOther
Primary outcome measure(s)

Incidence of Deep Venous Thrombosis after acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.

Key secondary outcome measure(s)

Predict model of VTE in acute stroke in China, measured at two weeks (14 ± 3 days) after stroke onset.

Completion date08/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Sex
Target sample size at registration1882
Key inclusion criteria1. 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
Key exclusion criteria1. Transient Ischaemic Attacks (TIAs)
2. Sub-Arachnoid Haemorrhage (SAH)
3. Tumour
4. Medical history of VTE
Date of first enrolment08/05/2007
Date of final enrolment08/10/2007

Locations

Countries of recruitment

  • China

Study participating centre

Tiantan Hospital
Beijing
100050
China

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Editorial Notes

19/10/2021: Proactive update review. No publications found. Search options exhausted.