Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222625
Status:
UNKNOWN
Last Update Posted:
2006-09-20
First Post:
2005-09-13
Brief Title:
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
Sponsor:
University Of Perugia
Organization:
University Of Perugia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 5-111000 patientsyear while the overall range of hemorrhages is about 621000 patientsyearIn 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 1415 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 procedures19 rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients
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 5-111000 patientsyear while the overall range of hemorrhages is about 621000 patientsyearIn 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 1415 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 procedures19 rFVIIa has also been reported to prevent or minimize refractory bleeding in non-coagulopathic patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04 MICV AI 04 | None | None | None |