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

February 3, 2009 updated by: IRCCS Policlinico S. Matteo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of product administration
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Matteo

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (ESTIMATE)

August 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS-SICH-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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