CompletedPhase 2

Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)

Italy30 participantsStarted 2005-01

Plain-language summary

Although the role of surgical treatment is still controversial, surgical evacuation of intracerebral hematoma is a frequent practice. Rebleeding is a frequent complication in patients submitted to hematoma evacuation. It has been reported that smaller postoperative volume of hematoma is associated with a better outcome. The investigators hypothesize that the administration of Factor VIIa (Eptacog alfa) immediately after surgical evacuation of the hematoma can reduce postoperative rebleeding. Aims of the Study: This study will investigate: 1. The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH; and 2. The safety of product administration

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, aged 18-75 years inclusive * Intraparenchymal primary supratentorial intracerebral hemorrhage requiring surgical evacuation * Any Glasgow Coma Score (GCS) score * Surgery expected to be performed within 24 hours from symptoms onset Exclusion Criteria: * Age below 18 * Intraparenchymal hematoma secondary to rupture of cerebral aneurysm or bleeding of arteriovenous (A-V) malformation or cerebral tumors * Contemporary involvement in another study * Pregnancy * Myocardial infarction in the six months preceding enrolment * Coronary or carotid stents positioned in the six months preceding enrolment * Solid organ transplant patients (e.g., heart, lung, liver, kidney) * Pregnancy * Myocardial infarction in the six months preceding enrolment * Coronary and carotid stents positioned in the six months preceding enrolment * Solid organ transplant patients (e.g., heart, lung, liver, kidney)

What they're measuring

Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH

Timeframe: 4 years

Trial details

NCT IDNCT00128050

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12