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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Intracerebral Hemorrhage trials