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

This study has been completed.
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00128050
First received: August 8, 2005
Last updated: February 3, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Intracerebral Hemorrhage
 Drug: rFactor VIIa (Eptacog alfa, NovoNordisk)
Drug: rFVIIa
Other: Sodiun chloride 0.9%
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of product administration [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Enrollment: 30
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128050

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

Publications:

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 
Study First Received: August 8, 2005
Last Updated: February 3, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

ClinicalTrials.gov processed this record on September 28, 2016