The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours

Hen Hallevi, Nicole R. Gonzales, Andrew D. Barreto, Sheryl Martin-Schild, Karen C. Albright, Elizabeth A. Noser, Kachi Illoh, Aslam M. Khaja, Teresa Allison, Miguel A. Escobar, Hashem Shaltoni, James C. Grotta

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

BACKGROUND AND PURPOSE - Recombinant-activated factor VII (rFVIIa) is an investigational treatment for intracerebral hemorrhage (ICH). We have evaluated the drug's treatment effect based on time to treatment. METHODS - ICH patients treated up to 4 hours from symptom onset were divided based on time to treatment: ≤3 hours (3H) and 3 to 4 hours (4H). Head CT was done at baseline and 24 hours. Outcome measures included: ICH growth at 24 hours, mortality, favorable outcome and discharge disposition. A cohort of nontreated matched ICH patients was used to asses the clinical efficacy. RESULTS - Forty-six patients were treated with rFVIIa: 24 in the 3H group (range 70 to 180 minutes), 22 in the 4H group (range 181 to 300). One hundred and forty-eight patients formed the control group. Mean baseline ICH volume was 8.8 mL for 3H and 10.1 mL for 4H. Mean 24-hour volume was 9.3 mL for 3H (absolute increase 1.05 mL, relative increase 11.9%) and 11.5 mL for 4H (absolute increase 1.1 mL, relative increase 10.9%); P=0.47 is for the difference in relative increase. Mortality was 12.5% for 3H group, 13.6% for 4H, and 13.1% for the control. In the 3H group, 58.3% were discharged with a poor outcome, compared with 54.5% in 4H and 54.1% in the control. Thrombotic adverse events occurred in 11.1% of patients treated with rFVIIa. CONCLUSIONS - In our off-label with rFVIIa, we did not find evidence of a treatment effect based on time to treatment. Other criteria should be sought to identify patients who might benefit clinically from rFVIIa.

Original languageEnglish (US)
Pages (from-to)473-475
Number of pages3
JournalStroke
Volume39
Issue number2
DOIs
StatePublished - Feb 1 2008
Externally publishedYes

Fingerprint

Factor VIIa
Cerebral Hemorrhage
Therapeutics
Investigational Therapies
Mortality
Equidae
Head
Outcome Assessment (Health Care)
recombinant FVIIa
Control Groups
Growth
Pharmaceutical Preparations

Keywords

  • Hematoma growth
  • Intracerebral hemorrhage
  • Recombinant-activated factor VII

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Hallevi, H., Gonzales, N. R., Barreto, A. D., Martin-Schild, S., Albright, K. C., Noser, E. A., ... Grotta, J. C. (2008). The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours. Stroke, 39(2), 473-475. https://doi.org/10.1161/STROKEAHA.107.497651

The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours. / Hallevi, Hen; Gonzales, Nicole R.; Barreto, Andrew D.; Martin-Schild, Sheryl; Albright, Karen C.; Noser, Elizabeth A.; Illoh, Kachi; Khaja, Aslam M.; Allison, Teresa; Escobar, Miguel A.; Shaltoni, Hashem; Grotta, James C.

In: Stroke, Vol. 39, No. 2, 01.02.2008, p. 473-475.

Research output: Contribution to journalArticle

Hallevi, H, Gonzales, NR, Barreto, AD, Martin-Schild, S, Albright, KC, Noser, EA, Illoh, K, Khaja, AM, Allison, T, Escobar, MA, Shaltoni, H & Grotta, JC 2008, 'The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours', Stroke, vol. 39, no. 2, pp. 473-475. https://doi.org/10.1161/STROKEAHA.107.497651
Hallevi H, Gonzales NR, Barreto AD, Martin-Schild S, Albright KC, Noser EA et al. The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours. Stroke. 2008 Feb 1;39(2):473-475. https://doi.org/10.1161/STROKEAHA.107.497651
Hallevi, Hen ; Gonzales, Nicole R. ; Barreto, Andrew D. ; Martin-Schild, Sheryl ; Albright, Karen C. ; Noser, Elizabeth A. ; Illoh, Kachi ; Khaja, Aslam M. ; Allison, Teresa ; Escobar, Miguel A. ; Shaltoni, Hashem ; Grotta, James C. / The effect of activated factor VII for intracerebral hemorrhage beyond 3 hours versus within 3 hours. In: Stroke. 2008 ; Vol. 39, No. 2. pp. 473-475.
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abstract = "BACKGROUND AND PURPOSE - Recombinant-activated factor VII (rFVIIa) is an investigational treatment for intracerebral hemorrhage (ICH). We have evaluated the drug's treatment effect based on time to treatment. METHODS - ICH patients treated up to 4 hours from symptom onset were divided based on time to treatment: ≤3 hours (3H) and 3 to 4 hours (4H). Head CT was done at baseline and 24 hours. Outcome measures included: ICH growth at 24 hours, mortality, favorable outcome and discharge disposition. A cohort of nontreated matched ICH patients was used to asses the clinical efficacy. RESULTS - Forty-six patients were treated with rFVIIa: 24 in the 3H group (range 70 to 180 minutes), 22 in the 4H group (range 181 to 300). One hundred and forty-eight patients formed the control group. Mean baseline ICH volume was 8.8 mL for 3H and 10.1 mL for 4H. Mean 24-hour volume was 9.3 mL for 3H (absolute increase 1.05 mL, relative increase 11.9{\%}) and 11.5 mL for 4H (absolute increase 1.1 mL, relative increase 10.9{\%}); P=0.47 is for the difference in relative increase. Mortality was 12.5{\%} for 3H group, 13.6{\%} for 4H, and 13.1{\%} for the control. In the 3H group, 58.3{\%} were discharged with a poor outcome, compared with 54.5{\%} in 4H and 54.1{\%} in the control. Thrombotic adverse events occurred in 11.1{\%} of patients treated with rFVIIa. CONCLUSIONS - In our off-label with rFVIIa, we did not find evidence of a treatment effect based on time to treatment. Other criteria should be sought to identify patients who might benefit clinically from rFVIIa.",
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AU - Noser, Elizabeth A.

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AB - BACKGROUND AND PURPOSE - Recombinant-activated factor VII (rFVIIa) is an investigational treatment for intracerebral hemorrhage (ICH). We have evaluated the drug's treatment effect based on time to treatment. METHODS - ICH patients treated up to 4 hours from symptom onset were divided based on time to treatment: ≤3 hours (3H) and 3 to 4 hours (4H). Head CT was done at baseline and 24 hours. Outcome measures included: ICH growth at 24 hours, mortality, favorable outcome and discharge disposition. A cohort of nontreated matched ICH patients was used to asses the clinical efficacy. RESULTS - Forty-six patients were treated with rFVIIa: 24 in the 3H group (range 70 to 180 minutes), 22 in the 4H group (range 181 to 300). One hundred and forty-eight patients formed the control group. Mean baseline ICH volume was 8.8 mL for 3H and 10.1 mL for 4H. Mean 24-hour volume was 9.3 mL for 3H (absolute increase 1.05 mL, relative increase 11.9%) and 11.5 mL for 4H (absolute increase 1.1 mL, relative increase 10.9%); P=0.47 is for the difference in relative increase. Mortality was 12.5% for 3H group, 13.6% for 4H, and 13.1% for the control. In the 3H group, 58.3% were discharged with a poor outcome, compared with 54.5% in 4H and 54.1% in the control. Thrombotic adverse events occurred in 11.1% of patients treated with rFVIIa. CONCLUSIONS - In our off-label with rFVIIa, we did not find evidence of a treatment effect based on time to treatment. Other criteria should be sought to identify patients who might benefit clinically from rFVIIa.

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