SELHIAS
Safety and Efficacy of Low-dose Heparin During Intracranial Angioplasty and Stent Placement
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Purpose:
To compare intra-operative two doses of heparin regimen (low dose verses high dose), and to evaluate safety and efficacy of low-dose heparin in patients undergoing intracranial angioplasty and stent placement.
Year Started:
2005
Year Finished:
2009
Design:
Randomized, double-blind, controlled, single-center trial.
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
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
Patient Involvement:
Patients are being randomly assigned to two groups, low-dose group who receive 2000 IU heparin intravenous bolus plus 500 IU/hr and high-dose group who receive 3000 IU heparin intravenous bolus plus 800 IU/hr after placement of an arterial sheath during intracranial angioplasty and stenting procedure.
Primary Outcome:
Efficacy end point will be the thrombo-embolic complications within 24 hour and safety end point will be intracranial bleeding complications within 24 hour of intracranial angioplasty and stenting procedure.
Secondary Outcome:
Intra-operative activated clotting time (ACT) and bleeding complications at puncture site.
Results:
The overall angioplasty success rate was 93% (65/70 lesions). Stents were placed in 94.7% (36/38) and 90.6% (29/32) of patients in the low-dose and high-dose groups, respectively (p = 0.65). The primary endpoint occurred in 6% (2/33) of patients in the low-dose group versus 16% (5/31) of patients in the high-dose group (p = 0.25). Two patients, 1 patient in each group, experienced acute target lesion thrombosis during the procedure (p = NS); ICH occurred in 5 patients: 1 in the low-dose group and 4 in high-dose group (3.0% versus 12.9%, p = 0.19). In conclusion, the use of a low-dose heparin regimen did not increase the incidence of target lesion thrombosis or ICH in this small pilot trial. Intraoperative low-dose heparin seems to be safe for patients undergoing intracranial stent-assisted angioplasty, but these data should be confirmed in a larger trial.
Source of Information:
Presented at the 2006 International Stroke Conference [February 2006].
Correspondence with trial coordinator.
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This information last updated on: 12/21/2009
Reviewed on: 10/05/2009.
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