The efficacy of factor VIIa in emergency department patients with warfarin use and traumatic intracranial hemorrhage

Daniel Nishijima, William E. Dager, Rudolph J. Schrot, James F Holmes Jr

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Objectives: The objective was to compare outcomes in emergency department (ED) patients with preinjury warfarin use and traumatic intracranial hemorrhage (tICH) who did and did not receive recombinant activated factor VIIa (rFVIIa) for international normalized ratio (INR) reversal. Methods: This was a retrospective before-and-after study conducted at a Level 1 trauma center, with data from 1999 to 2009. Eligible patients had preinjury warfarin use and tICH on cranial computed tomography (CT) scan. Patients before (standard cohort) and after (rFVIIa cohort) implementation of a protocol for administering 1.2 mg of rFVIIa in the ED were reviewed. Glasgow Coma Scale (GCS) score, Revised Trauma Score (RTS), Injury Severity Score (ISS), INR, and Marshall score were collected. Outcome measures included mortality, thromboembolic complications, and INR normalization. Results: Forty patients (median age = 80.5 years, interquartile range [IQR] = 63.5-85) were included (20 in each cohort). Age, GCS score, ISS, RTS, initial INR, and Marshall score were similar (p > 0.05) between the two cohorts. Survival was identical between cohorts (13 of 20, or 65.0%, 95% confidence interval [CI] = 40.8% to 84.6%). There were no differences in rate of thromboembolic complications in the standard cohort (1 of 20, 5.0%, 95% CI = 0.1% to 24.9%) than the rFVIIa cohort (4 of 20, 20.0%, 95% CI = 5.7% to 43.7%; p = 0.34). Time to normal INR was earlier in the rFVIIa cohort (mean = 4.8 hours, 95% CI = 3.0 to 6.7 hours) than in the standard cohort (mean = 17.5 hours, 95% CI = 12.5 to 22.6; p < 0.001). Conclusions: In patients with preinjury warfarin and tICH, use of rFVIIa was associated with a decreased time to normal INR. However, no difference in mortality was identified. Use of rFVIIa in patients on warfarin and tICH requires further study to demonstrate important patient-oriented outcomes.

Original languageEnglish (US)
Pages (from-to)244-251
Number of pages8
JournalAcademic Emergency Medicine
Volume17
Issue number3
DOIs
StatePublished - 2010

Fingerprint

Traumatic Intracranial Hemorrhage
Factor VIIa
Warfarin
International Normalized Ratio
Hospital Emergency Service
Confidence Intervals
Glasgow Coma Scale
Injury Severity Score
Mortality
Trauma Centers
Wounds and Injuries
recombinant FVIIa
Tomography
Outcome Assessment (Health Care)
Survival

Keywords

  • Factor VII
  • Traumatic intracranial hemorrhage
  • Warfarin

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

The efficacy of factor VIIa in emergency department patients with warfarin use and traumatic intracranial hemorrhage. / Nishijima, Daniel; Dager, William E.; Schrot, Rudolph J.; Holmes Jr, James F.

In: Academic Emergency Medicine, Vol. 17, No. 3, 2010, p. 244-251.

Research output: Contribution to journalArticle

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abstract = "Objectives: The objective was to compare outcomes in emergency department (ED) patients with preinjury warfarin use and traumatic intracranial hemorrhage (tICH) who did and did not receive recombinant activated factor VIIa (rFVIIa) for international normalized ratio (INR) reversal. Methods: This was a retrospective before-and-after study conducted at a Level 1 trauma center, with data from 1999 to 2009. Eligible patients had preinjury warfarin use and tICH on cranial computed tomography (CT) scan. Patients before (standard cohort) and after (rFVIIa cohort) implementation of a protocol for administering 1.2 mg of rFVIIa in the ED were reviewed. Glasgow Coma Scale (GCS) score, Revised Trauma Score (RTS), Injury Severity Score (ISS), INR, and Marshall score were collected. Outcome measures included mortality, thromboembolic complications, and INR normalization. Results: Forty patients (median age = 80.5 years, interquartile range [IQR] = 63.5-85) were included (20 in each cohort). Age, GCS score, ISS, RTS, initial INR, and Marshall score were similar (p > 0.05) between the two cohorts. Survival was identical between cohorts (13 of 20, or 65.0{\%}, 95{\%} confidence interval [CI] = 40.8{\%} to 84.6{\%}). There were no differences in rate of thromboembolic complications in the standard cohort (1 of 20, 5.0{\%}, 95{\%} CI = 0.1{\%} to 24.9{\%}) than the rFVIIa cohort (4 of 20, 20.0{\%}, 95{\%} CI = 5.7{\%} to 43.7{\%}; p = 0.34). Time to normal INR was earlier in the rFVIIa cohort (mean = 4.8 hours, 95{\%} CI = 3.0 to 6.7 hours) than in the standard cohort (mean = 17.5 hours, 95{\%} CI = 12.5 to 22.6; p < 0.001). Conclusions: In patients with preinjury warfarin and tICH, use of rFVIIa was associated with a decreased time to normal INR. However, no difference in mortality was identified. Use of rFVIIa in patients on warfarin and tICH requires further study to demonstrate important patient-oriented outcomes.",
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AU - Nishijima, Daniel

AU - Dager, William E.

AU - Schrot, Rudolph J.

AU - Holmes Jr, James F

PY - 2010

Y1 - 2010

N2 - Objectives: The objective was to compare outcomes in emergency department (ED) patients with preinjury warfarin use and traumatic intracranial hemorrhage (tICH) who did and did not receive recombinant activated factor VIIa (rFVIIa) for international normalized ratio (INR) reversal. Methods: This was a retrospective before-and-after study conducted at a Level 1 trauma center, with data from 1999 to 2009. Eligible patients had preinjury warfarin use and tICH on cranial computed tomography (CT) scan. Patients before (standard cohort) and after (rFVIIa cohort) implementation of a protocol for administering 1.2 mg of rFVIIa in the ED were reviewed. Glasgow Coma Scale (GCS) score, Revised Trauma Score (RTS), Injury Severity Score (ISS), INR, and Marshall score were collected. Outcome measures included mortality, thromboembolic complications, and INR normalization. Results: Forty patients (median age = 80.5 years, interquartile range [IQR] = 63.5-85) were included (20 in each cohort). Age, GCS score, ISS, RTS, initial INR, and Marshall score were similar (p > 0.05) between the two cohorts. Survival was identical between cohorts (13 of 20, or 65.0%, 95% confidence interval [CI] = 40.8% to 84.6%). There were no differences in rate of thromboembolic complications in the standard cohort (1 of 20, 5.0%, 95% CI = 0.1% to 24.9%) than the rFVIIa cohort (4 of 20, 20.0%, 95% CI = 5.7% to 43.7%; p = 0.34). Time to normal INR was earlier in the rFVIIa cohort (mean = 4.8 hours, 95% CI = 3.0 to 6.7 hours) than in the standard cohort (mean = 17.5 hours, 95% CI = 12.5 to 22.6; p < 0.001). Conclusions: In patients with preinjury warfarin and tICH, use of rFVIIa was associated with a decreased time to normal INR. However, no difference in mortality was identified. Use of rFVIIa in patients on warfarin and tICH requires further study to demonstrate important patient-oriented outcomes.

AB - Objectives: The objective was to compare outcomes in emergency department (ED) patients with preinjury warfarin use and traumatic intracranial hemorrhage (tICH) who did and did not receive recombinant activated factor VIIa (rFVIIa) for international normalized ratio (INR) reversal. Methods: This was a retrospective before-and-after study conducted at a Level 1 trauma center, with data from 1999 to 2009. Eligible patients had preinjury warfarin use and tICH on cranial computed tomography (CT) scan. Patients before (standard cohort) and after (rFVIIa cohort) implementation of a protocol for administering 1.2 mg of rFVIIa in the ED were reviewed. Glasgow Coma Scale (GCS) score, Revised Trauma Score (RTS), Injury Severity Score (ISS), INR, and Marshall score were collected. Outcome measures included mortality, thromboembolic complications, and INR normalization. Results: Forty patients (median age = 80.5 years, interquartile range [IQR] = 63.5-85) were included (20 in each cohort). Age, GCS score, ISS, RTS, initial INR, and Marshall score were similar (p > 0.05) between the two cohorts. Survival was identical between cohorts (13 of 20, or 65.0%, 95% confidence interval [CI] = 40.8% to 84.6%). There were no differences in rate of thromboembolic complications in the standard cohort (1 of 20, 5.0%, 95% CI = 0.1% to 24.9%) than the rFVIIa cohort (4 of 20, 20.0%, 95% CI = 5.7% to 43.7%; p = 0.34). Time to normal INR was earlier in the rFVIIa cohort (mean = 4.8 hours, 95% CI = 3.0 to 6.7 hours) than in the standard cohort (mean = 17.5 hours, 95% CI = 12.5 to 22.6; p < 0.001). Conclusions: In patients with preinjury warfarin and tICH, use of rFVIIa was associated with a decreased time to normal INR. However, no difference in mortality was identified. Use of rFVIIa in patients on warfarin and tICH requires further study to demonstrate important patient-oriented outcomes.

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