Intracerebral HemorrhagePhase 2NCT00222625
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
A Phase 2 study testing rFVIIa + (vit K in AO patients) and FFP or aPCC+ vit K in AO treated patients in people with Intracerebral Hemorrhage, run by University Of Perugia at 9 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- rFVIIa + (vit K in AO patients) and FFP or aPCC+ vit K in AO treated patients
- How many people
- 32 participants
- Where
- 9 sitesItaly
- Study dates
- Sep 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites, 9 recruiting
- Recruiting
A.O.R.N. San Sebastiano
Caserta
Tiscione Vitagliano
- Recruiting
Emergency Room
Forlì
Alberto Randelli
- Recruiting
Emergency Department - S.Martino Hospital
Genoa
Fiorella Altomonte, MD
Paolo Moscatelli, MD
- Recruiting
Emergency Room - University of Messina
Messina
Maria Gioffrè, Professor
- Recruiting
Internal and Vascular Medicine - Stroke Unit - University of Perugia
Perugia
Agnelli Giancarlo, Professor
Agnelli Giancarlo, Professor
- Recruiting
Divisione di Neurologia
Piacenza
Donata Guidetti, MD
- Recruiting
Emergency Room
Ravenna
Raffaele Nocenti
- Recruiting
Emergency Room
Reggio Emilia
Angelo Ghirarduzzi
- Recruiting
Stroke Unit - Policlinico Universitario Umberto I
Rome
Danilo Toni, Professor
About this study
Official title: Randomized, Open, Prospective, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII in Acute Intracerebral Haemorrhage in Patients Treated With Oral Anticoagulants or Antiplatelets Agents.
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
Read the detailed description
Intracerebral hemorrhage (ICH) is the deadliest, most disabling, and least treatable form of stroke. Approximately 40% of patients die within 1 month of ICH onset, and two-thirds of survivors never regain functional independence. Though guidelines for supportive care exist, there is currently no treatment that has been shown in a randomized-controlled trial to definitely improve outcome after ICH. Hematoma volume is a critical determinant of mortality and functional outcome after ICH, and early hematoma growth may be an important cause of early neurological deterioration.
Considerable clinical interest has been given to the relationship between antiplatelet and antithrombotic treatment and ICH.
The reported incidence of major bleeding events in patients undergoing antithrombotic treatment is 5-11/1,000 patients/year, while the overall range of hemorrhages is about 62/1,000 patients/year.In the patients treated with antithrombotic drugs (oral anticoagulants or antiplatelets agent) the incidence rate of ICH has been shown higher than in the general population. Moreover, the mortality rate for both spontaneous and post-traumatic events is higher in antithrombotic treated patients than in controls. [14,15] rFVIIa has been successfully used to control ICH in patients with hemophilia or other coagulation disorders, and can arrest intraoperative bleeding and reverse coagulopathies in patients undergoing neurosurgical procedures.[19] rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- rFVIIa + (vit K in AO patients), FFP or aPCC+ vit K in AO treated patients
- Keywords
- Intracerebral Hemorrhage, Oral Anticoagulants, Antiplatelet Agents, Recombinant Activated Factor VII
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFVIIa + (vit K in AO patients)Drug
FFP or aPCC+ vit K in AO treated patientsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Investigators
- Alfonso Iorio, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222625
- Sponsor's protocol ID
- 2005-002155-40
- Other IDs
- 04 MICV AI 04, 2005
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2006
- Results posted
- No
Publications
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.
PubMed 37870112Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171.
PubMed 18289410
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Prospective, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII in Acute Intracerebral Haemorrhage in Patients Treated With Oral Anticoagulants or Antiplatelets Agents.
- ClinicalTrials.gov ID
- NCT00222625
- Acronym / sponsor ID
- 2005-002155-40
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Oral Anticoagulants, Antiplatelet Agents, Recombinant Activated Factor VII
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Sep 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Intracerebral hemorrhage (ICH) is the deadliest, most disabling, and least treatable form of stroke. Approximately 40% of patients die within 1 month of ICH onset, and two-thirds of survivors never regain functional independence. Though guidelines for supportive care exist, there is currently no treatment that has been shown in a randomized-controlled trial to definitely improve outcome after ICH. Hematoma volume is a critical determinant of mortality and functional outcome after ICH, and early hematoma growth may be an important cause of early neurological deterioration.
Considerable clinical interest has been given to the relationship between antiplatelet and antithrombotic treatment and ICH.
The reported incidence of major bleeding events in patients undergoing antithrombotic treatment is 5-11/1,000 patients/year, while the overall range of hemorrhages is about 62/1,000 patients/year.In the patients treated with antithrombotic drugs (oral anticoagulants or antiplatelets agent) the incidence rate of ICH has been shown higher than in the general population. Moreover, the mortality rate for both spontaneous and post-traumatic events is higher in antithrombotic treated patients than in controls. [14,15] rFVIIa has been successfully used to control ICH in patients with hemophilia or other coagulation disorders, and can arrest intraoperative bleeding and reverse coagulopathies in patients undergoing neurosurgical procedures.[19] rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rFVIIa + (vit K in AO patients) | Drug | – |
| FFP or aPCC+ vit K in AO treated patients | Drug | – |
Primary outcome
EFFICACY: change in ICH volume from prior to dosing to 24 hours
SAFETY: occurrence of clinical adverse events (Thromboembolic events, death)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2006.
- Derived from this study: PubMed 37870112Eilertsen 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.
- Derived from this study: PubMed 18289410Iorio A. Iatrogenic causes of an ICH: OAT therapy. Eur J Anaesthesiol Suppl. 2008;42:8-11. doi: 10.1017/S0265021507003171.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Iorio principal investigator
University Of Perugia
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rFVIIa + (vit K in AO patients) and FFP or aPCC+ vit K in AO treated patients in people with Intracerebral Hemorrhage, run by University Of Perugia at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfonso Iorio, MD (075 578 4306, iorioa@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY: change in ICH volume from prior to dosing to 24 hours. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222625, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2006.