Condition category
Circulatory System
Date applied
28/04/2007
Date assigned
06/06/2007
Last edited
06/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Beijing Tiantan Hospital (China)

Sponsor details

c/o Professor Yongjun Wang
Affiliated Hospital of Capital Medical University
Beijing
100050
China

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes