Efficacy and Safety of Factor VIIa on Rebleeding After Surgery for Spontaneous Intracerebral Hemorrhage (ICH) (PRE-SICH)
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| ClinicalTrials.gov Identifier: NCT00128050 |
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Recruitment Status :
Completed
First Posted : August 9, 2005
Last Update Posted : February 4, 2009
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intracerebral Hemorrhage | Drug: rFactor VIIa (Eptacog alfa, NovoNordisk) Drug: rFVIIa Other: Sodiun chloride 0.9% | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Patients treated with recombinant FVIIa
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Drug: rFactor VIIa (Eptacog alfa, NovoNordisk)
rFVIIa will be admistered as single bolus at the dosage of 100 mcg/Kg b.w. Drug: rFVIIa Patients with spontaneous supratentorial ICH will be treated with rFVII after hematoma evacuation |
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Placebo Comparator: 2
Patients with spontaneous supratentorial ICH included in this arm will be treated with placebo
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Other: Sodiun chloride 0.9%
Bolus injection of sodium chloride 0.9% after surgical hematoma removal |
- Evaluate the efficacy of Factor VIIa (Eptacog alfa) in preventing or reducing rebleeding after surgery for spontaneous supratentorial ICH [ Time Frame: 4 years ]
- Safety of product administration [ Time Frame: 4 years ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128050
| Italy | |
| Azienda Ospedaliera S. Croce e Carle | |
| Cuneo, Italy, 12100 | |
| Azienda Ospedaliera "Maggiore della Carità" | |
| Novara, Italy, 28100 | |
| II Dpt Anesthesiology&Critical Care Medicine - IRCCS Policlinico S. Matteo | |
| Pavia, Italy, 27100 | |
| Principal Investigator: | Roberto Imberti, M.D. | IRCCS Policlinico S. Matteo - Pavia - Italy |
Publications:
| Responsible Party: | Roberto Imberti, M.D., Fondazione IRCCS Policlinico S. Matteo |
| ClinicalTrials.gov Identifier: | NCT00128050 History of Changes |
| Other Study ID Numbers: |
NS-SICH-2005 |
| First Posted: | August 9, 2005 Key Record Dates |
| Last Update Posted: | February 4, 2009 |
| Last Verified: | February 2009 |
Keywords provided by IRCCS Policlinico S. Matteo:
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Spontaneous intracerebral hemorrhage ICH intracerebral rebleeding cerebral hematoma evacuation cerebral hematoma volume |
Additional relevant MeSH terms:
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Hemorrhage Cerebral Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |