ArticleInternational journal of stroke : official journal of the International Stroke Society2022
Recombinant factor VIIa for hemorrhagic stroke treatment at earliest possible time (FASTEST): Protocol for a phase III, double-blind, randomized, placebo-controlled trial.
Article in International journal of stroke : official journal of the International Stroke Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03496883 (Recombinant Factor VIIa), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage.The Cochrane database of systematic reviews · 2023Pooled it
- Intraventricular Hemorrhage Expansion in the CLEAR III Trial: A Post Hoc Exploratory Analysis.Stroke · 2022Trial
- Minimal Fibrinolysis After Acute Intracerebral Hemorrhage Undercuts the Mechanism of Tranexamic Acid.Journal of the American Heart Association · 2026Article
- Therapeutic strategies in intracerebral hemorrhage: from hematoma stabilization to alleviating secondary brain injury.Research and practice in thrombosis and haemostasis · 2026Review
- Association of Thromboelastography With Hematoma Expansion and Disability in Spontaneous Intracerebral Hemorrhage: A Multicenter Study.Neurology open access · 2026Article
- Influence of spot sign on the association between rapidly achieving blood pressure reduction and intracerebral haemorrhage outcomes.European stroke journal · 2026Article
- A decision tree model for hematoma expansion prediction in women after spontaneous intracerebral hemorrhage.Frontiers in neurology · 2026Article
- Prehospital intensive blood pressure management in intracerebral hemorrhage: current evidence, controversies, and future directions.Frontiers in medicine · 2026Review
- Article
- Intracerebral Hemorrhage in Aging: Pathophysiology, Clinical Challenges, and Future Directions.Life (Basel, Switzerland) · 2025Review
- Predictive modeling of hematoma expansion from non-contrast computed tomography in spontaneous intracerebral hemorrhage patients.medRxiv : the preprint server for health sciences · 2025Article
- Improving the Robustness of Deep Learning Models in Predicting Hematoma Expansion from Admission Head CT.AJNR. American journal of neuroradiology · 2025Article
- Spot Sign in Intracerebral Hemorrhage: Critical Reappraisal and Future Clinical Implications.Stroke · 2025Review
- Optimizing Automated Hematoma Expansion Classification from Baseline and Follow-Up Head Computed Tomography.Applied sciences (Basel, Switzerland) · 2025Article
- Medical Management of Acute Stroke based on Japan Stroke Society Guidelines and the Japan Stroke Data Bank.Journal of atherosclerosis and thrombosis · 2024Review
- Combined effect of cortical superficial siderosis and cerebral microbleed on short-term and long-term outcomes after intracerebral haemorrhage.Stroke and vascular neurology · 2024Observational
- Evolution and Future of Stroke Trials.Stroke · 2024Review
- P2Y12 inhibitor use predicts hematoma expansion in patients with intracerebral hemorrhage.Annals of clinical and translational neurology · 2024Article
- Remote Ischemic Conditioning to Reduce Perihematoma Edema in Patients with Intracerebral Hemorrhage (RICOCHET): A Randomized Control Trial.Journal of clinical medicine · 2024Article
- Prehospital identification of intracerebral haemorrhage: a scoping review of early clinical features and portable devices.BMJ open · 2024Article
Corrections and comments
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Authors and funding
16 authors at 11 institutions in 6 countries.
Funding
Abstract
introductionIntracerebral hemorrhage is the deadliest form of stroke. Hematoma expansion, growth of the hematoma between the baseline computed tomography scan and a follow-up computed tomography scan at 24 ± 6 h, predicts long-term disability or death. Recombinant factor VIIa (rFVIIa) has reduced hematoma expansion in previous clinical trials with a variable effect on clinical outcomes, with the greatest impact on hematoma expansion and potential benefit when administered within 2 h of symptom onset.
methodsFactor VIIa for Hemorrhagic Stroke Treatment at Earliest Possible Time (FASTEST, NCT03496883) is a randomized controlled trial that will enroll 860 patients at ∼100 emergency departments and mobile stroke units in five countries. Patients are eligible for enrollment if they have acute intracerebral hemorrhage within 2 h of symptom onset confirmed by computed tomography, a hematoma volume of 2 to 60 mL, no or small volumes of intraventricular hemorrhage, do not take anticoagulant medications or concurrent heparin/heparinoids (antiplatelet medications are permissible), and are not deeply comatose. Enrolled patients will receive rFVIIa 80 µg/kg or placebo intravenously over 2 min. The primary outcome measure is the distribution of the ordinal modified Rankin Scale at 180 days. FASTEST is monitored by a Data Safety Monitoring Board. Safety endpoints include thrombotic events (e.g. myocardial infarction). Human subjects research is monitored by an external Institutional Review Board in participating countries. DISCUSSION: In the US, FASTEST will be first NIH StrokeNet Trial with an Exception from Informed Consent which allows enrollment of non-communicative patients without an immediately identifiable proxy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.