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

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Drug: rFactor VIIa (Eptacog alfa, NovoNordisk); Drug: rFVIIa; Other: Sodiun chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT00128050

NS-SICH-2005

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Patients treated with recombinant FVIIa

Treatment:

Drug: rFactor VIIa (Eptacog alfa, NovoNordisk)

Drug: rFVIIa

2

Placebo Comparator group

Description:

Patients with spontaneous supratentorial ICH included in this arm will be treated with placebo

Treatment:

Other: Sodiun chloride 0.9%