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Reducing the risk of ICH enlargement
Katja E Wartenberg1, Stephan A Mayer
1Neurological Intensive Care Unit, Columbia-Presbyterian Medical Center, New York, NY, USA.
Insights
Early treatment with recombinant activated factor VII (rFVIIa) significantly reduced brain hemorrhage expansion, mortality, and improved outcomes in stroke patients. This hemostatic therapy shows promise for improving survival and function after intracerebral hemorrhage.
Area of Science:
- Neurology
- Hematology
- Emergency Medicine
Background:
- Intracerebral hemorrhage (ICH) is a severe stroke type with high mortality and poor outcomes.
- Hematoma volume is a key predictor of mortality and patient prognosis.
- Early hematoma expansion occurs in a significant percentage of ICH patients, worsening outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of recombinant activated factor VII (rFVIIa) in treating acute intracerebral hemorrhage.
- To determine if ultra-early hemostatic therapy can prevent hematoma growth and improve patient outcomes.
Main Methods:
- A phase IIb randomized, double-blind, placebo-controlled, dose-ranging trial involving 399 patients with non-coagulopathic ICH.
- Administration of rFVIIa within 4 hours of symptom onset.
- Assessment of hematoma expansion at 24 hours, and mortality and functional outcomes at 90 days.
Main Results:
- rFVIIa administration significantly reduced hematoma expansion at 24 hours post-ICH.
- Treatment with rFVIIa led to reduced mortality rates at 90 days.
- Improved functional outcomes were observed in patients treated with rFVIIa.
Conclusions:
- Ultra-early hemostatic therapy with rFVIIa is a safe and feasible approach for managing intracerebral hemorrhage.
- rFVIIa effectively reduces hematoma expansion, mortality, and improves functional outcomes in ICH patients.
- Further confirmation is being sought in a phase III trial (The FAST Trial).
Abstract:
Intracerebral hemorrhage (ICH) comprises 15% of all strokes, and carries the highest risk of mortality and poor long-term outcome. ICH has long been recognized as the least treatable form of stroke, and hematoma volume as the strongest single predictor of mortality and outcome. CT-based studies have found that early substantial hematoma expansion occurs in 18-38% of patients initially scanned within 3 h of symptom onset. This finding is associated with early neurological deterioration and an increased risk of poor outcome. Ultra-early hemostatic therapy might be beneficial in preventing hematoma growth, resulting in improved mortality and neurological function. Recombinant activated factor VII (rFVIIa) promotes local hemostasis in the presence or absence of coagulopathy at sites of vascular injury, and is a promising treatment for arresting active bleeding in ICH. The safety and feasibility of this approach was confirmed in a phase IIb randomized, double-blind, placebo-controlled, dose-ranging trial of 399 patients with non-coagulopathic ICH. Administration of rFVIIa within 4 h of ICH onset resulted in a significant reduction of hematoma expansion at 24 h, and reduced mortality and improved functional outcome at 90 days. A confirmatory phase III trial (The FAST Trial) to confirm these results will complete enrollment in the end of 2006.
