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 hepari
- Conditions
- SurgeryIschemic stroke attributed to an intracranial stenosisIntracranial angioplasty
- Registration Number
- ISRCTN48605341
- Lead Sponsor
- The Ministry of Health of the People's Republic of China
- Brief Summary
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19842721 (added 23/05/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Efficacy end point was thromboembolus complications within 24h.<br> 2. Safety end point was intracranial bleeding complications within 24h.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Intraoperative activated clotting time monitoring<br> 2. Puncture site complications<br>