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

Intracerebral Hemorrhage Clinical Trial

— PRE-SICH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128050
• Other study ID #: NS-SICH-2005
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2005
• Last updated: February 3, 2009
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• rFactor VIIa (Eptacog alfa, NovoNordisk)
rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.
• rFVIIa
Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation

Other:
• Sodiun chloride 0.9%
Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo
Italy	Azienda Ospedaliera "Maggiore della Carità"	Novara
Italy	II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH		4 years
Secondary	Safety of product administration		4 years