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February 23, 2015Critical CareOpen Access

Benefit profile of recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis

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Key result

Recombinant human soluble thrombomodulin administration was significantly associated with reduced in-hospital mortality in high-risk patients with sepsis-induced DIC (APACHE II 24-29) (HR 0.281).

Why the study?

Does recombinant human soluble thrombomodulin reduce in-hospital mortality in patients with sepsis-induced DIC requiring ventilator management?

Population

162 patients with sepsis-induced disseminated intravascular coagulation who required ventilator management

Comparison

Recombinant human soluble thrombomodulin (rhTM) vs No rhTM

Design

Cohort

Follow-up

in-hospital

Authors

JYJumpei YoshimuraOsaka Prefectural Medical CenterKYKazuma YamakawaOsaka Medical and Pharmaceutical UniversityHOHiroshi OguraOsaka Gakuin University

Discussion

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Implication

May support rhTM in high-risk sepsis DIC; leaves open confirmation by RCTs before practice change.

Study Design

Type

Cohort (n=162)

Multicenter

Yes

Structured PICO

Does recombinant human soluble thrombomodulin reduce in-hospital mortality in patients with sepsis-induced DIC requiring ventilator management?

P
Population
162 mechanically ventilated patients with sepsis-induced disseminated intravascular coagulation (DIC) treated at three Japanese tertiary referral hospitals.
E
Exposure
Recombinant human soluble thrombomodulin (rhTM)
C
Comparator
No rhTM
O
Outcome
In-hospital mortalityhard clinical

Main Result

Hazard Ratio: 0.281 (95% CI 0.093–0.85)

p-value: p=0.025

Recombinant human soluble thrombomodulin may provide a survival benefit in patients with sepsis-induced DIC who have a high baseline risk of death (APACHE II 24-29 or SOFA ≥11).

Limitations

  • Retrospective observational design, not a randomized controlled trial
  • Long time span of the study could have introduced confounding therapeutic measures
  • Treatment intervention was not standardized (e.g., dose and duration)
  • Baseline characteristics differed between the two groups
  • Potential for false positive results due to subgroup analysis
  • Inadequate power to uncover treatment effect differences (risk of false negatives)

Cite This Study

Yoshimura et al. (2015) conducted a cohort in Sepsis-induced disseminated intravascular coagulation (DIC) (n=162). Recombinant human soluble thrombomodulin (rhTM) vs. No rhTM was evaluated on In-hospital mortality in high-risk patients (APACHE II: 24 to 29) (HR 0.281, 95% CI 0.093 to 0.850, p=0.025). Recombinant human soluble thrombomodulin administration was significantly associated with reduced in-hospital mortality in high-risk patients with sepsis-induced DIC (APACHE II 24-29) (HR 0.281).

synapsesocial.com/papers/6a93ea1b8e5b8037ce43e5cdhttps://doi.org/10.1186/s13054-015-0810-3
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Thrombomodulin-Protein C-EPCR System2004 · 368 citations
  2. 2A multicenter, prospective validation of disseminated intravascular coagulation diagnostic criteria for critically ill patients: Comparing current criteria*2006 · 656 citations
  3. 3Recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis2013 · 116 citations
  4. 4Estimating Treatment Effects Using Observational Data2007 · 357 citations
  5. 5Drotrecogin Alfa (Activated) for Adults with Severe Sepsis and a Low Risk of Death2005 · 897 citations