Randomised, Open, Prospective, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Activated Recombinant Factor Viia (Novoseven) in Acute Intracerebral Haemorrhage in Patients Treated With Oral Anticoagulant or Antiplatelet Agents

Iorio, Alfonso; Marchesini, Emanuela; Falcou, Anne; Caso, Valeria; Pastorello, Maurizio; Tiscione, V.; Ballarino, Paola; Altomonte, F; Baldi, Giovanni; Agnelli, Giancarlo; Toni, Danilo

doi:10.1111/j.1538-7836.2007.tb01920.x

Cited by 4 publications

(2 citation statements)

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“…14 Eight articles were 41 ; and 1 used a control group that received activated prothrombin complex concentrates (11 subjects). 42 Additional information in 4 studies was kindly provided by the investigators or by NovoNordisk. 16,21,28,42 Further, 1 article was written originally in Chinese and translated.…”

Section: Resultsmentioning

confidence: 99%

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Use of Recombinant Activated Factor VII in Patients Without Hemophilia

Hsia¹,

Chin‐Yee²,

McAlister³

2008

Annals of Surgery

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Context: Benefits of recombinant activated factor VII (rFVIIa) in hemorrhage may be lost because of thromboembolic events (TAE). Method: MEDLINE, EMBASE, BIOSIS, CINAHL, Science Citation Index Expanded, clinicaltrials.gov were searched for placebo controlled trials of rFVIIa in patients without hemophilia. Reports of 22 randomized controlled trials were selected for analysis. Results were pooled using random effects models to calculate the odds ratios (OR) with 95% confidence interval (CI). Subgroup analyses were predetermined. Results: Among 3184 participants, 478 (15.0%) died and 249 (7.8%) had TAE. Additional blood transfusion was required in 517 (41.2%) of 1256 subjects. Patients receiving rFVIIa were less likely to need additional blood transfusions (OR, 0.54; 95% CI, 0.34 -0.86) than patients receiving placebo. Mortality was not increased but may be reduced (OR, 0.88; 95% CI, 0.71-1.09). Reduction in mortality was more likely if rFVIIa was given therapeutically (OR, 0.87; 95% CI, 0.70 -1.09) rather than prophylactically (OR, 1.00; 95% CI, 0.37-2.68). Differences in the pooled analysis of TAE were not statistically significant (OR, 1.17; 95% CI, 0.87-1.58) but the incidence of arterial TAE was likely higher in patients receiving rFVIIa (OR, 1.50; 95% CI, 0.93-2.41) although no differences were seen with respect to venous TAE (OR, 0.76; 95% CI, 0.49 -1.15). Conclusions: Use of rFVIIa reduces the need for blood transfusion and it may reduce mortality, especially if the dose of rFVIIa is limited to therapeutic doses of 90 g/kg. It does not increase the risk of venous thrombosis but it may increase the risk of arterial thrombosis. (Ann Surg 2008;248: 61-68)

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Section: Resultsmentioning

confidence: 99%

“…Four of the reports were in abstract form only. 16,21,28,42 These 29 articles were independently reviewed and 21 reports of 22 randomized clinical controlled trials met inclusion criteria. One article included 2 parallel, randomized controlled trials.…”

Section: Resultsmentioning

confidence: 99%