NCT00222625

Brief Summary

Evaluation of efficacy and safety of recombinant factor VIIa versus standard therapy in preventing early haematoma growth in spontaneous acute intracerebral haemorrhage in patients treated with oral anticoagulants or antiplatelets agents

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
unknown

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

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 19, 2006

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral HemorrhageOral AnticoagulantsAntiplatelet AgentsRecombinant Activated Factor VII

Outcome Measures

Primary Outcomes (2)

  • EFFICACY: change in ICH volume from prior to dosing to 24 hours

  • SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)

Secondary Outcomes (1)

  • Difference between groups on the modified Rankin Scale, the Barthel Index (BI), the Extended Glasgow Scale (EGCS), and the National Institute of Health's Stroke Scale (NIHSS) at one and three month follow up

Interventions

rFVIIa + (vit K in AO patients)DRUG
FFP or aPCC+ vit K in AO treated patientsDRUG

Eligibility Criteria

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

You may qualify if:

  • ICH in patient on treatment with one of the following:
  • a)oral anticoagulant (INR upper than 1,4 at enrollment
  • b) aspirin, whatever dosage
  • Male or female subjects, age \> 18 years.
  • Informed consent

You may not qualify if:

  • INR below 1.4 for patients on oral anticoagulants.
  • Patients with secondary ICH related to infarction, tumor, cerebrovenous thrombosis, thrombolysis.
  • Planned neurosurgical intervention.
  • Any history of haemophilia or other congenital or acquired coagulopathy requiring specific antihemorrhagic treatment.
  • Acute myocardial ischaemia or acute thrombotic stroke (within one year).
  • Septicemia, intravascular disseminated coagulation.
  • Pregnancy.
  • Limb amputation due to vascular disease or claudication within last 30 days.
  • Known or suspected allergy to the trial product or related products.
  • Participation in other trials within the previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

A.O.R.N. San Sebastiano

Caserta, Italy

RECRUITING

Emergency Room

Forlì, Italy

RECRUITING

Emergency Department - S.Martino Hospital

Genoa, Italy

RECRUITING

Emergency Room - University of Messina

Messina, Italy

RECRUITING

Internal and Vascular Medicine - Stroke Unit - University of Perugia

Perugia, Italy

RECRUITING

Divisione di Neurologia

Piacenza, Italy

RECRUITING

Emergency Room

Ravenna, Italy

RECRUITING

Emergency Room

Reggio Emilia, Italy

RECRUITING

Stroke Unit - Policlinico Universitario Umberto I

Rome, Italy

RECRUITING

Related Publications (2)

  • 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

  • Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171.

    PMID: 18289410DERIVED

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

  • Alfonso Iorio

    University Of Perugia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Iorio, MD

CONTACT

075 578 4306iorioa@unipg.it

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

IT(9)