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

ISRCTN	ISRCTN48605341
DOI	https://doi.org/10.1186/ISRCTN48605341
Protocol serial number	2004BA714B-7
Sponsor	The Ministry of Health of the People's Republic of China
Funder	The Ministry of Health of The People's Republic of China

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jiang Wei-Jian
Scientific

No. 6 Tiantan Xili
Beijing
100050
China

Phone	+86 1067050137
Email	cjr.jiangweijian@vip.163.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study acronym	SELHIAS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Intracranial angioplasty
Intervention	Stent-assisted angioplasty of the offending intracranial stenosis
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Heparin
Primary outcome measure(s)	1. Efficacy end point was thromboembolus complications within 24h. 2. Safety end point was intracranial bleeding complications within 24h.
Key secondary outcome measure(s)	1. Intraoperative activated clotting time monitoring 2. Puncture site complications
Completion date	01/02/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Not Specified
Target sample size at registration	60
Total final enrolment	64
Key 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
Key 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
Date of first enrolment	01/02/2005
Date of final enrolment	01/02/2006

No. 6 Tiantan Xili

Beijing
100050
China

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2009	23/05/2019	Yes	No

23/05/2019: Publication reference and total final enrolment added.