Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies

Vincent, Jean‐Louis; Nadel, Simon; Kutsogiannis, Demetrios J; Gibney, RT Noel; Yan, S. Betty; Wyss, V; Bailey, Joan; Mitchell, Clifford L.; Sarwat, Samiha; Shinall, Stephen M; Janes, Jonathan

doi:10.1186/cc3538

Cited by 59 publications

(8 citation statements)

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“…Or, practically speaking, after a lumbar puncture is performed upon admission (for which prior reversal of anticoagulant therapy is necessary), is it advisable to immediately resume anticoagulant therapy? Previous studies on the effect of anticoagulant therapies in bacterial meningitis showed a higher rate of hemorrhagic complications and mortality [14], [15]. In a retrospective analysis of several open-label, placebo controlled and compassionate-use trials of activated protein C (APC), intracranial hemorrhage was seen in 6% of patients treated with APC compared to 3% of patients receiving placebo or no APC.…”

Section: Discussionmentioning

confidence: 99%

Intracerebral Hemorrhages in Adults with Community Associated Bacterial Meningitis in Adults: Should We Reconsider Anticoagulant Therapy?

et al. 2012

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ObjectiveTo study the incidence, clinical presentation and outcome of intracranial hemorrhagic complications in adult patients with community associated bacterial meningitis.MethodsNationwide prospective cohort study from all hospitals in the Netherlands, from 1 March 2006, through 31 December 2010.ResultsOf the 860 episodes of bacterial meningitis that were included, 24 were diagnosed with intracranial hemorrhagic complications: 8 upon presentation and 16 during clinical course. Clinical presentation between patients with or without intracranial hemorrhage was similar. Causative bacteria were Streptococcus pneumoniae in 16 patients (67%), Staphylococcus aureus in 5 (21%), Pseudomonas aeruginosa and Listeria monocytogenes both in 1 patient (4%). Occurrence of intracranial hemorrhage was associated with death (63% vs. 15%, P<0.001) and unfavorable outcome (94% vs. 34%, P<0.001). The use of anticoagulants on admission was associated with a higher incidence of intracranial hemorrhages (odds ratio 5.84, 95% confidence interval 2.17–15.76).ConclusionIntracranial hemorrhage is a rare but devastating complication in patients with community-associated bacterial meningitis. Since anticoagulant therapy use is associated with increased risk for intracranial hemorrhage, physicians may consider reversing or temporarily discontinuing anticoagulation in patients with bacterial meningitis.

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Section: Discussionmentioning

confidence: 99%

Intracerebral Hemorrhages in Adults with Community Associated Bacterial Meningitis in Adults: Should We Reconsider Anticoagulant Therapy?

et al. 2012

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“…[9][10][11][12][13][14] Patients with an infection of the head or neck, however, were not included in these trials, and it is unknown whether this recommendation should apply to these patients. Limited data suggest that anticoagulant therapy in patients with meningitis is associated with a higher rate of intracerebral hemorrhagic complications 15 and increased mortality. 16 With the exception of case reports, 17,18 there are no data on the use of heparin in patients with CVT and a concurrent infection.…”

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confidence: 99%

Clinical Outcome of Anticoagulant Treatment in Head or Neck Infection–Associated Cerebral Venous Thrombosis

Zuurbier

Coutinho

Stam

et al. 2016

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Background and Purpose-Local infections of the head or neck are a cause of cerebral venous thrombosis. Treatment of infectious cerebral venous thrombosis with heparin is controversial. We examined whether this treatment was associated with intracranial hemorrhagic complications and poor clinical outcome. Methods-We retrieved data from a prospective cohort study of 624 cerebral venous thrombosis patients. We compared patients with and without an infection of the head or neck and anticoagulated versus not anticoagulated. We examined death or dependency and new intracerebral hemorrhages. Results-Six hundred four of 624 patients were eligible for the study. Fifty-seven patients had an infection of the head or neck (9.4%). Comparing data between infection and noninfection patients, the frequency of therapeutic doses of heparin was similar in both groups (82.5% versus 83.7%). New intracerebral hemorrhages were more common in patients with an infection (12.3% versus 5.3%; P=0.04), but death or dependency did not differ between patients with and without an infection (15.8% versus 13.7%). In patients with an infection of the head or neck, there was no significant difference in the frequency of new intracerebral hemorrhages and poor outcome between patients who did or did not receive therapeutic doses of heparin. Conclusions-New intracerebral hemorrhages were more frequent in patients with an infection. The use of therapeutic doses of heparin did not seem to influence the risk of new intracranial hemorrhages or poor clinical outcome, but the number of patients who did not receive anticoagulation was too small to draw firm conclusions about safety of heparin in adults with cerebral venous thrombosis and an infection of the head or neck.

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“…Other studies have explored the use of activated PC in patients with PF. Vincent and colleagues published a post-hoc analysis of recent studies using activated PC in adult and pediatric patients with severe sepsis, presenting with PF, meningitis or meningococcal disease [ 5 ]. The authors identified 119 pediatric patients suitable for the analysis, 87 of them with PF.…”

Section: Discussionmentioning

confidence: 99%

Human protein C concentrate in the treatment of purpura fulminans: a retrospective analysis of safety and outcome in 94 pediatric patients

et al. 2010

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IntroductionPurpura fulminans (PF) is a devastating complication of uncontrolled systemic inflammation, associated with high incidence of amputations, skin grafts and death. In this study, we aimed to clarify the clinical profile of pediatric patients with PF who improved with protein C (PC) treatment, explore treatment effects and safety, and to refine the prognostic significance of protein C plasma levels.MethodsIn Germany, patients receiving protein C concentrate (Ceprotin®, Baxter AG, Vienna, Austria) are registered. The database was used to locate all pediatric patients with PF treated with PC from 2002 to 2005 for this national, retrospective, multi-centered study.ResultsComplete datasets were acquired in 94 patients, treated in 46 centers with human, non-activated protein C concentrate for purpura fulminans. PC was given for 2 days (median, range 1-24 days) with a median daily dose of 100 IU/kg. Plasma protein C levels increased from a median of 27% to a median of 71% under treatment. 22.3% of patients died, 77.7% survived to discharge. Skin grafts were required in 9.6%, amputations in 5.3%. PF recovered or improved in 79.8%, remained unchanged in 13.8% and deteriorated in 6.4%. Four adverse events occurred in 3 patients, none classified as severe. Non-survivors had lower protein C plasma levels (P < 0.05) and higher prevalence of coagulopathy at admission (P < 0.01). Time between admission and start of PC substitution was longer in patients who died compared to survivors (P = 0.03).ConclusionsThis retrospective dataset shows that, compared to historic controls, only few pediatric patients with PF under PC substitution needed dermatoplasty and/or amputations. Apart from epistaxis, no bleeding was observed. Although the data comes from a retrospective study, the evidence we present suggests that PC had a beneficial impact on the need for dermatoplasty and amputations, pointing to the potential value of carrying out a prospective randomised controlled trial.

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Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies

Cited by 59 publications

References 54 publications

Intracerebral Hemorrhages in Adults with Community Associated Bacterial Meningitis in Adults: Should We Reconsider Anticoagulant Therapy?

Intracerebral Hemorrhages in Adults with Community Associated Bacterial Meningitis in Adults: Should We Reconsider Anticoagulant Therapy?

Clinical Outcome of Anticoagulant Treatment in Head or Neck Infection–Associated Cerebral Venous Thrombosis

Human protein C concentrate in the treatment of purpura fulminans: a retrospective analysis of safety and outcome in 94 pediatric patients

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