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
Safety and Efficacy of Low-dose Heparin during Intracranial Angioplasty and Stent placement: a randomized, double-blind, controlled study of 2000 IU versus 3000 IU bolus heparin
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 measure
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 (if study stopped)
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
Total final enrolment
64
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
Basic results (scientific)
Publication list
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19842721 (added 23/05/2019)