Clinical trial NCT00128050: Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
Official title: Efficacy and Safety of Factor VIIa (Eptacog Alfa) on Rebleeding After Surgery for Spontaneous Supratentorial Intracerebral Hemorrhage. A Randomized, Controlled, Open-Label, Investigator-Blinded Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Spontaneous intracerebral hemorrhage
ICH
intracerebral rebleeding
cerebral hematoma evacuation
cerebral hematoma volume
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2005-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH
timeFrame: 4 years
Secondary outcomes:
measure: Safety of product administration
timeFrame: 4 years
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
city: Novara
country: Italy
facility: Azienda Ospedaliera "Maggiore della Carità"
city: Pavia
country: Italy
facility: II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo
Study officials:
affiliation: IRCCS Policlinico S. Matteo - Pavia - Italy
name: Roberto Imberti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgenstern LB, Demchuk AM, Kim DH, Frankowski RF, Grotta JC. Rebleeding leads to poor outcome in ultra-early craniotomy for intracerebral hemorrhage. Neurology. 2001 May 22;56(10):1294-9. doi: 10.1212/wnl.56.10.1294.