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

NCT ID: NCT00128050

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Patients treated with recombinant FVIIa

Group Type: ACTIVE_COMPARATOR

rFactor VIIa (Eptacog alfa, NovoNordisk)

Intervention Type: DRUG

rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.

rFVIIa

Intervention Type: DRUG

Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation

2

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

Group Type: PLACEBO_COMPARATOR

Sodiun chloride 0.9%

Intervention Type: OTHER

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Interventions

rFactor VIIa (Eptacog alfa, NovoNordisk)

rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.

Intervention Type: DRUG

rFVIIa

Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation

Intervention Type: DRUG

Sodiun chloride 0.9%

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Fondazione IRCCS Policlinico S. Matteo

Principal Investigators

Roberto Imberti, M.D.

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico S. Matteo - Pavia - Italy

Locations

Azienda Ospedaliera S. Croce e Carle

Cuneo, Cuneo, Italy

Azienda Ospedaliera "Maggiore della Carità"

Novara, , Italy

II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo

Pavia, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 11376176 (View on PubMed)

Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.

Reference Type: DERIVED

PMID: 37870112 (View on PubMed)

Other Identifiers

NS-SICH-2005

Identifier Type: -

Identifier Source: org_study_id