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Prevalence of Thromboembolism in Severe Sepsis: Retrospective Survey of Patients Assigned to Placebo Groups of Randomized Controlled Trials FREE TO VIEW

Robert Levine, MD; Jacques LeClerc, MD
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University of Texas Health Sciences Center, Houston, TX


Chest. 2003;124(4_MeetingAbstracts):121S. doi:10.1378/chest.124.4_MeetingAbstracts.121S
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PURPOSE:  Though patients with severe sepsis harbor many risk factors for arterial and venous thrombotic events (TE), few data exist on the prevalence of events. We conducted a retrospective analysis of TE prevalence among 1221 severe sepsis patients assigned to the placebo treatment group in 3 randomized trials of novel therapeutic agents, in addition to standard of care.

METHODS:  Enrollment criteria were similar among trials, including suspected or proven infection and ≥ 1 sepsis-induced organ dysfunction(s). Thrombotic events were prospectively obtained from investigator serious adverse event reports during these studies, through 28 days following treatment. Main results (baseline characteristics and TEs) are shown below.

RESULTS:  PROWESS Placebo (n = 840)Phase 2 Trial A Placebo (n = 196)Phase 2 Trial B Placebo (n = 185)Aggregate Placebo (n = 1221)Mean age, years ± SD60.6 ± 16.557.3 ± 16.560.8 ± 17.060.1 ± 28.9Male gender, n (%)487 (58.0)116 (59.2)96 (51.9)699 (57.2)Mean APACHE II ± SD25.0 ± 7.823.6 ± 7.725.6 ± 7.824.9 ± 13.5Mechanical ventilation, n (%)652 (77.6)160 (81.6)148 (80.0)960 (78.6)Ischemic stroke, n (%)10 (1.2)2 (1.0)5 (2.7)17 (1.4)Myocardial infarction, n (%)10 (1.2)0010 (0.8)Pulmonary embolism, n (%)5 (0.6)01 (0.5)6 (0.5)Lower extremity deep vein thrombosis, n (%)1 (0.1)1 (0.5)1 (0.5)3 (0.2)Internal jugular vein thrombosis, n (%)002 (1.0)2 (0.2)Lower extremity embolism, n (%)01 (0.5)01 (0.1)Thrombosis NOS, n (%)1 (0.1)01 (0.5)2 (0.2)Total thromboembolic events, n (%)27 (3.2)4 (2.0)10 (5.3)41 (3.4)

CONCLUSION:  Sepsis severity was comparable among trials, based on indices surveyed. Overall TEs were reported in 3.4% of all patients and included events often associated with death, such as stroke and myocardial infarction. Ischemic stroke accounted for 41.4% of the total prevalence. Overall prevalence may be underestimated, as patients were not assessed uniformly for TEs in these studies.CLINICAL IMPLICATION: These data warrant further exploration, particularly concerning ischemic stroke and acute myocardial infarction. We are also in the process of evaluating DIC in these patients.

DISCLOSURE:  R. Levine, None.

Tuesday, October 28, 2003

2:30 PM - 4:00 PM




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