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

NCT00128050 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-04

No results posted yet for this study

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

Conditions

  • Intracerebral Hemorrhage

Interventions

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

OTHER

Sodiun chloride 0.9%

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Roberto Imberti, M.D. · IRCCS Policlinico S. Matteo - Pavia - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00128050 on ClinicalTrials.gov