Intracerebral Hemorrhage
Conditions
Keywords
Spontaneous intracerebral hemorrhage, ICH, intracerebral rebleeding, cerebral hematoma evacuation, cerebral hematoma volume
Brief 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
Detailed description
The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH. All patients included in the study will perform a CT scan within 3 hours before surgery, then immediately after surgery, and 18-30 hours after surgery. The hematoma volume will be evaluated by a multi-slice CT scan. All CT scan images will be sent to the Coordinating Center where the hematoma volume will be evaluated by a dedicated software by the same investigator who will be unaware of the treatment (investigator- blinded study). SAFETY EVALUATION: Seventeen episodes of thrombotic spontaneous adverse events have been reported after administration of 480,000 standard doses of Eptacog alfa in hemophilic patients. These episodes include myocardial infarction, acute cerebrovascular thrombosis, disseminated intravascular coagulation (DIC), deep venous thrombosis (DVT) and pulmonary embolism. Before and after hematoma removal will be evaluated ECG, myocardiac enzymes, coagulation profile, CT scan (looking for ischemic events) and venous echodoppler ultrasound of lower extremities.
Interventions
DRUGrFactor VIIa (Eptacog alfa, NovoNordisk)
rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.
DRUGrFVIIa
Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation
OTHERSodiun chloride 0.9%
Bolus injection of sodium chloride 0.9% after surgical hematoma removal
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Safety of product administration | 4 years |
Countries
Italy
Outcome results
None listed