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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage	Drug: rFactor VIIa (Eptacog alfa, NovoNordisk); Drug: rFVIIa; Other: Sodiun chloride 0.9%	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
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 Start Date :	January 2005
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; Patients treated with recombinant FVIIa	Drug: rFactor VIIa (Eptacog alfa, NovoNordisk); rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w. Drug: rFVIIa; Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation
Placebo Comparator: 2; Patients with spontaneous supratentorial ICH included in this arm will be treated with placebo	Other: Sodiun chloride 0.9%; Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Outcome Measures

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Primary Outcome Measures :

1. Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH [ Time Frame: 4 years ]

Secondary Outcome Measures :

1. Safety of product administration [ Time Frame: 4 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Locations

Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy, 12100
Azienda Ospedaliera "Maggiore della Carità"
Novara, Italy, 28100
II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo
Pavia, Italy, 27100

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

Investigators

Principal Investigator:	Roberto Imberti, M.D.	IRCCS Policlinico S. Matteo - Pavia - Italy

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Responsible Party:	Roberto Imberti, M.D., Fondazione IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:	NCT00128050 History of Changes
Other Study ID Numbers:	NS-SICH-2005
First Posted:	August 9, 2005
Last Update Posted:	February 4, 2009
Last Verified:	February 2009

Keywords provided by IRCCS Policlinico S. Matteo:

Spontaneous intracerebral hemorrhage; ICH; intracerebral rebleeding; cerebral hematoma evacuation; cerebral hematoma volume

Additional relevant MeSH terms:

Hemorrhage; Cerebral Hemorrhage; Pathologic Processes; Intracranial Hemorrhages; Cerebrovascular Disorders	Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases