"Evaluation of the impact of the dose of heparin on the occurrence of DWI ischemic lesions after embolization of unruptured intracranial aneurysm" "HARMONI"

Conditions

Intracranial aneurysms

Brief summary

Percentage of the presence of at least one recent ischemic lesion visible on diffusion-weighted MRI at 24 hours postoperatively, in each treatment arm.

Detailed description

Rate of intraoperative angiographic thromboembolic events in each arm, Proportion of subjects with more than 5 punctate ischemic lésions, or a territorial ischemic stroke visible on diffusion-weighted MRI at 24 hours postoperatively, in each arm., Mean volume of recent ischemic lesions on diffusion-weighted MRI at 24 hours postoperatively, in each arm, Rate of subjects with symptomatic ischemic stroke within 24 hours postoperatively , in each arm., NIHSS score at 24 hours postoperatively in each arm, Rate of major hemorrhagic events (intraoperative or within the first 24 hours postoperatively) in each arm, Rate of minor hemorrhagic events (intraoperative or within the first 24 hours postoperatively), Proportion of subjects who experienced any ischemic event within 24 hours after the procedure.

Related papers

No related papers found yet.

Interventions

DRUGHEPARINE SODIQUE PANPHARMA 5 000 UI/ml

DRUGsolution injectable (I.V.)

DRUGPROTAMINE SULFATE

DRUGACETYLSALICYLIC ACID

DRUGTICAGRELOR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of the presence of at least one recent ischemic lesion visible on diffusion-weighted MRI at 24 hours postoperatively, in each treatment arm.	—

Secondary

Measure	Time frame
Rate of intraoperative angiographic thromboembolic events in each arm, Proportion of subjects with more than 5 punctate ischemic lésions, or a territorial ischemic stroke visible on diffusion-weighted MRI at 24 hours postoperatively, in each arm., Mean volume of recent ischemic lesions on diffusion-weighted MRI at 24 hours postoperatively, in each arm, Rate of subjects with symptomatic ischemic stroke within 24 hours postoperatively , in each arm., NIHSS score at 24 hours postoperatively in each arm, Rate of major hemorrhagic events (intraoperative or within the first 24 hours postoperatively) in each arm, Rate of minor hemorrhagic events (intraoperative or within the first 24 hours postoperatively), Proportion of subjects who experienced any ischemic event within 24 hours after the procedure.	—

Measure

Time frame

Rate of intraoperative angiographic thromboembolic events in each arm, Proportion of subjects with more than 5 punctate ischemic lésions, or a territorial ischemic stroke visible on diffusion-weighted MRI at 24 hours postoperatively, in each arm., Mean volume of recent ischemic lesions on diffusion-weighted MRI at 24 hours postoperatively, in each arm, Rate of subjects with symptomatic ischemic stroke within 24 hours postoperatively , in each arm., NIHSS score at 24 hours postoperatively in each arm, Rate of major hemorrhagic events (intraoperative or within the first 24 hours postoperatively) in each arm, Rate of minor hemorrhagic events (intraoperative or within the first 24 hours postoperatively), Proportion of subjects who experienced any ischemic event within 24 hours after the procedure.

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Outcome results

None listed