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NCT Number: NCT00128050

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

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

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rFactor VIIa (Eptacog alfa, NovoNordisk)

Drug

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

rFVIIa

Drug

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

Sodiun chloride 0.9%

Other

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

Primary outcomes

  1. Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH

    Time frame: 4 years

Secondary outcomes

  1. Safety of product administration

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study 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

Acronym: PRE-SICH

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 9, 2005
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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