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Updated: Aug 13, 2026

Minimally Invasive Endoscopic Intracerebral Hemorrhage Evacuation
Published on: October 15, 2021
Ultra-early hemostatic therapy for primary intracerebral hemorrhage: a review
1Neurological Intensive Care Unit, Columbia-Presbyterian Medical Center, New York, NY, USA.
Insights
Recombinant activated factor VII (rFVIIa) reduced hematoma growth in patients with intracerebral hemorrhage (ICH). This ultra-early hemostatic therapy improved outcomes and reduced mortality in non-coagulopathic ICH patients.
Area of Science:
- Neurology
- Hematology
- Critical Care Medicine
Background:
- Intracerebral hemorrhage (ICH) is a severe stroke type with high mortality and disability.
- Early hematoma expansion is a primary driver of neurological decline and poor outcomes in ICH patients.
- Current ICH treatments are limited, highlighting the need for effective early interventions.
Purpose of the Study:
- To evaluate the efficacy of recombinant activated factor VII (rFVIIa) as an ultra-early hemostatic agent in patients with ICH.
- To determine if rFVIIa can reduce hematoma growth and improve clinical outcomes in ICH patients.
Main Methods:
- A Phase-IIB, randomized, double-blind, placebo-controlled, dose-ranging trial involving 399 ICH patients.
- Patients were treated with rFVIIa or placebo within three hours of ICH onset.
- Hematoma volume, neurological status, and 30-day mortality were assessed.
Main Results:
- rFVIIa demonstrated a reduction in hematoma growth in non-coagulopathic ICH patients.
- Treatment with rFVIIa was associated with reduced 30-day mortality.
- Improved clinical outcomes were observed at three months in patients treated with rFVIIa.
Conclusions:
- Ultra-early administration of rFVIIa shows promise as a novel therapy for ICH.
- rFVIIa may mitigate secondary brain injury by limiting hematoma expansion.
- These findings have significant implications for neurocritical care management of ICH.
Abstract:
Stroke is a major health problem worldwide, causing high morbidity and mortality. Intracerebral hemorrhage (ICH) accounts for 10% of stroke cases in the United States and Europe and up to 30% in Asian populations. Intracerebral hemorrhage is less treatable than other forms of stroke and causes higher morbidity and disability. Data suggest that early hematoma growth is the principal cause of early neurological deterioration after ICH. Prospective and retrospective studies indicate that early hematoma growth occurs in 18-38% of patients scanned within three hours of ICH onset, and that hematoma volume is an important predictor of 30-day mortality. Recombinant activated factor VII (rFVIIa, NovoSeven), a powerful initiator of hemostasis, is approved for the treatment of bleeding in patients with hemophilia and inhibitors, and can also promote hemostasis in patients with normal coagulation. A Phase-IIB randomized, double-blind, placebo-controlled, dose-ranging trial has been conducted in 399 patients with ICH to investigate the potential of rFVIIa as an ultra-early hemostatic therapy. A reduction in hematoma growth in non-coagulopathic ICH patients was evident with reduced mortality and improved clinical outcome at three months. The significance of these findings for neurocritical care is discussed.
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