Condition category
Surgery
Date applied
29/08/2005
Date assigned
14/09/2005
Last edited
03/10/2007
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

Dr Jiang Wei-Jian

ORCID ID

Contact details

No. 6 Tiantan Xili
Beijing
100050
China
+86 1067050137
cjr.jiangweijian@vip.163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2004BA714B-7

Study information

Scientific title

Acronym

SELHIAS

Study hypothesis

H0: low-dose heparin (2000 IU) group has more thromboembolus complications and similar intracranial bleeding complications compared with standard-dose of heparin (3000 IU) group during intracranial angioplasty and stent placement.

H1: low-dose heparin (2000 IU) group has fewer intracranial bleeding complications and similar thromboembolus complications compared with standard-dose of heparin (3000 IU)group during intracranial angioplasty and stent placement.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Intracranial angioplasty

Intervention

Stent-assisted angioplasty of the offending intracranial stenosis

Intervention type

Drug

Phase

Not Specified

Drug names

Heparin

Primary outcome measures

1. Efficacy end point was thromboembolus complications within 24h.
2. Safety end point was intracranial bleeding complications within 24h.

Secondary outcome measures

1. Intraoperative activated clotting time monitoring
2. Puncture site complications

Overall trial start date

01/02/2005

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-75 years of age
2. Recurrent ischemic events (transient ischemic attack and/or stroke) attributed to an intracranial stenosis ≥ 50% at digital subtraction angiography (DSA)
3. Performed intracranial angioplasty and stent placement

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Intracranial hemorrhage and major ischemic stroke (NIHSS ≥8) in the same hemisphere as the target lesion within 6 weeks
2. Concurrent severe extracranial artery stenosis and angioplasty and stent placement needed to be performed
3. Concurrent intracranial tumors, cerebral AVM and aneurysms
4. History of heparin allergy
5. Received perioperative heparin or surgical procedures requiring systemic heparinization
6. Preoperative platelet or coagulation abnormalities
7. Patients were not eligible if they could not cooperate with the study procedures or provide informed consent

Recruitment start date

01/02/2005

Recruitment end date

01/02/2006

Locations

Countries of recruitment

China

Trial participating centre

No. 6 Tiantan Xili
Beijing
100050
China

Sponsor information

Organisation

The Ministry of Health of the People's Republic of China

Sponsor details

No.1 The South Road of Xizhimenwai
Beijing
100044
China
manluzhu@yahoo.com.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Ministry of Health of The People's Republic of 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