NCT00128050

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. 1.The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH; and
  2. 2.The safety of product administration

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

Enrollment Period

3.9 years

First QC Date

August 8, 2005

Last Update Submit

February 3, 2009

Conditions

Intracerebral Hemorrhage

Keywords

Spontaneous intracerebral hemorrhageICHintracerebral rebleedingcerebral hematoma evacuationcerebral hematoma volume

Outcome Measures

Primary Outcomes (1)

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

    4 years

Secondary Outcomes (1)

  • Safety of product administration

    4 years

Study Arms (2)

1

ACTIVE COMPARATOR

Patients treated with recombinant FVIIa

Drug: rFactor VIIa (Eptacog alfa, NovoNordisk)Drug: rFVIIa

2

PLACEBO COMPARATOR

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

Other: Sodiun chloride 0.9%

Interventions

rFactor VIIa (Eptacog alfa, NovoNordisk)DRUG

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

1
rFVIIaDRUG

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

1
Sodiun chloride 0.9%OTHER

Bolus injection of sodium chloride 0.9% after surgical hematoma removal

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Azienda Ospedaliera S. Croce e Carle

Cuneo, Cuneo, 12100, Italy

Location

Azienda Ospedaliera "Maggiore della Carità"

Novara, 28100, Italy

Location

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

Pavia, 27100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 11376176BACKGROUND

  • 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.

    PMID: 37870112DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Imberti, M.D.

    IRCCS Policlinico S. Matteo - Pavia - Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

IT(3)