Key result
Soluble thrombomodulin pharmacokinetics do not differ significantly in DIC patients with severe renal impairment.
Why the study?
The pharmacokinetics and pharmacodynamics of recombinant human soluble thrombomodulin (TM-α) in DIC patients with severe renal impairment have not yet been elucidated.
Does severe renal impairment alter the pharmacokinetics and pharmacodynamics of recombinant human soluble thrombomodulin in patients with disseminated intravascular coagulation?
Comparison
DIC patients with severe renal impairment vs without severe renal impairment receiving TM-α
Design
Cohort study
Follow-up
24 hours
Authors
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May warrant trough monitoring with repeated TM-α dosing in renal impairment; leaves open need for outcome studies in DIC.
Cohort (n=21)
No
Does severe renal impairment alter the pharmacokinetics and pharmacodynamics of recombinant human soluble thrombomodulin in patients with disseminated intravascular coagulation?
Although single-dose pharmacokinetics of TM-α are similar in DIC patients with and without severe renal impairment, caution is needed with repeated dosing due to potential accumulation.
Hayakawa et al. (2012) conducted a cohort in Disseminated intravascular coagulation (DIC) (n=21). Recombinant human soluble thrombomodulin (TM-α) vs. DIC patients without severe renal impairment (CLcr ≥ 30 ml/min) was evaluated on Pharmacokinetic parameters (clearance, elimination half-life, maximum concentration, volume of distribution at steady-state). The pharmacokinetic parameters of recombinant human soluble thrombomodulin were not significantly different between DIC patients with and without severe renal impairment, though simulations indicated trough levels may gradually increase with repeated dosing in those with renal impairment.
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