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ISRCTN
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ISRCTN48605341
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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SELHIAS
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Serial number at source
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2004BA714B-7
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Intracranial angioplasty
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/02/2005
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Anticipated end date
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01/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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Stent-assisted angioplasty of the offending intracranial stenosis
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Primary outcome measure(s)
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1. Efficacy end point was thromboembolus complications within 24h.
2. Safety end point was intracranial bleeding complications within 24h.
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Secondary outcome measure(s)
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1. Intraoperative activated clotting time monitoring
2. Puncture site complications
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Sources of funding
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The Ministry of Health of The People's Republic of China
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Trial website
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Publications
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Contact name
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Dr
Jiang
Wei-Jian
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Address
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No. 6 Tiantan Xili
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Tel
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+86 1067050137
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Fax
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+86 1067050137
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Email
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cjr.jiangweijian@vip.163.com
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Sponsor
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The Ministry of Health of the People's Republic of China
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Address
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No.1 The South Road of Xizhimenwai
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City/town
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Beijing
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Zip/Postcode
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100044
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Country
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China
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Email
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manluzhu@yahoo.com.cn
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Date applied
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29/08/2005
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Last edited
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03/10/2007
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Date ISRCTN assigned
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14/09/2005
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