June 15, 1995Blood
Inhibition of endotoxin-induced activation of the coagulation and fibrinolytic pathways using a recombinant endotoxin-binding protein (rBPI23)
Key result
rBPI23 significantly reduced the endotoxin-induced activation of the fibrinolytic and coagulation systems after low-dose endotoxin infusion compared to placebo (P=0.0078 for multiple markers).
Why the study?
Does rBPI23 reduce endotoxin-induced activation of the fibrinolytic and coagulation systems in human volunteers?
Study Design
Type
RCT (n=8)
Blinding
Blinded
Structured PICO
Does rBPI23 reduce endotoxin-induced activation of the fibrinolytic and coagulation systems in human volunteers?
P
Population
8 volunteers undergoing experimental endotoxemia via intravenous bolus injection of endotoxin.
I
Intervention
rBPI23 (1 mg/kg) administered concurrently with endotoxin
C
Comparator
Placebo (human serum albumin, 0.2 mg/kg) administered concurrently with endotoxin
O
Outcome
Endotoxin-induced activation of the fibrinolytic and coagulation systems (release of tissue-type plasminogen activator, urokinase-type plasminogen activator, plasminogen activator inhibitor antigen, complex formation of plasmin alpha 2-antiplasmin, F1 + 2 fragments, and TAT complexes)surrogate
Main Result
p-value: p=.0078
rBPI23 partially prevents the activation of fibrinolytic and coagulation pathways induced by low-dose endotoxin in humans.
Authors
Discussion
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Implication
rBPI23 attenuates endotoxin-driven coagulopathy in volunteers; extends preclinical data and supports trials in clinical sepsis.
Cite This Study
Mohlen et al. (1995) conducted an RCT in Experimental endotoxemia (n=8). rBPI23 vs. Placebo (human serum albumin, 0.2 mg/kg) was evaluated on Endotoxin-induced fibrinolytic response (release of t-PA, u-PA, PAI antigen, and plasmin alpha 2-antiplasmin complex) (p=.0078). rBPI23 significantly reduced the endotoxin-induced activation of the fibrinolytic and coagulation systems after low-dose endotoxin infusion compared to placebo (P=0.0078 for multiple markers).