Intracerebral HemorrhagePhase 2PRE-SICHNCT00128050
Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH)
A Phase 2 study testing rFactor VIIa (Eptacog alfa, NovoNordisk), rFVIIa and Sodiun chloride 0.9% in people with Intracerebral Hemorrhage, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- rFactor VIIa (Eptacog alfa, NovoNordisk), rFVIIa and Sodiun chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2005to Dec 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Azienda Ospedaliera S. Croce e Carle
Cuneo, Cuneo, 12100
Azienda Ospedaliera "Maggiore della Carità"
Novara, 28100
II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo
Pavia, 27100
About this study
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
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:
- The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH; and
- The safety of product administration
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- rFactor VIIa (Eptacog alfa, NovoNordisk), rFVIIa, Sodiun chloride 0.9%
- Keywords
- Spontaneous intracerebral hemorrhage, ICH, intracerebral rebleeding, cerebral hematoma evacuation, cerebral hematoma volume
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFactor VIIa (Eptacog alfa, NovoNordisk)Drug
rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w.
rFVIIaDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients treated with recombinant FVIIa Receives: 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 Receives: Other: Sodiun chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH
Measured: 4 years
Secondary outcomes (1)
Safety of product administration
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2008
- Study completionDec 2008
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.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Investigators
- Roberto Imberti, M.D., Principal investigator, IRCCS Policlinico S. Matteo - Pavia - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128050
- Sponsor's protocol ID
- NS-SICH-2005
- Acronym
- PRE-SICH
- Status last verified
- Feb 2009
- First submitted
- 8 Aug 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11376176Eilertsen 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 37870112
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00128050
- Acronym / sponsor ID
- PRE-SICH / NS-SICH-2005
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Spontaneous intracerebral hemorrhage, ICH, intracerebral rebleeding, cerebral hematoma evacuation, cerebral hematoma volume
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Aug 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.
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:
- The efficacy of Eptacog alfa in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH; and
- The safety of product administration
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: rFactor VIIa (Eptacog alfa, NovoNordisk), Drug: rFVIIaPatients treated with recombinant FVIIa |
| 2 | Placebo comparator | Other: Sodiun chloride 0.9%Patients with spontaneous supratentorial ICH included in this arm will be treated with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| rFactor VIIa (Eptacog alfa, NovoNordisk)rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w. | Drug | 1 |
| rFVIIaPatients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation | Drug | 1 |
| Sodiun chloride 0.9%Bolus injection of sodium chloride 0.9% after surgical hematoma removal | Other | 2 |
Primary outcome
Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH
Time frame: 4 years
1 secondary outcome
Safety of product administration
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Background: PubMed 11376176Morgenstern 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.
- 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.
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
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.
Roberto Imberti, M.D. principal investigator
IRCCS Policlinico S. Matteo - Pavia - Italy
3 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 rFactor VIIa (Eptacog alfa, NovoNordisk), rFVIIa and Sodiun chloride 0.9% in people with Intracerebral Hemorrhage, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH (time frame: 4 years). 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 NCT00128050, 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 4 Feb 2009.