Monitoring of argatroban and lepirudin anticoagulation in critically ill patients by conventional laboratory parameters and rotational thromboelastometry — ALicia substudy
Randomized double-blind clinical trial published in BMC Anesthesiology (2018)
Abstract
BACKGROUND: Argatroban or lepirudin anticoagulation therapy in patients with heparin induced thrombocytopenia (HIT) or HIT suspect is typically monitored using the activated partial thromboplastin time (aPTT). Although aPTT correlates well with plasma levels of argatroban and lepirudin in healthy volunteers, it might not be the method of choice in critically ill patients. However, in-vivo data is lacking for this patient population. Therefore, we studied in vivo whether ROTEM or global clotting times would provide an alternative for monitoring the anticoagulant intensity effects in critically ill patients. METHODS: This study was part of the double-blind randomized trial "Argatroban versus Lepirudin in critically ill patients (ALicia)", which compared critically ill patients treated with argatroban or lepirudin. Following institutional review board approval and written informed consent, for this sub-study blood of 35 critically ill patients was analysed. Before as well as 12, 24, 48 and 72 h after initiation of argatroban or lepirudin infusion, blood was analysed for aPTT, aPTT ratios, thrombin time (TT), INTEM CT,INTEM CT ratios, EXTEM CT, EXTEM CT ratios and maximum clot firmness (MCF) and correlated with the corresponding plasma concentrations of the direct thrombin inhibitor. RESULTS: To reach a target aPTT of 1.5 to 2 times baseline, median [IQR] plasma concentrations of 0.35 [0.01-1.2] μg/ml argatroban and 0.17 [0.1-0.32] μg/ml lepirudin were required. For both drugs, there was no significant correlation between aPTT and aPTT ratios and plasma concentrations. INTEM CT, INTEM CT ratios, EXTEM CT, EXTEM CT ratios, TT and TT ratios correlated significantly with plasma concentrations of both drugs. Additionally, agreement between argatroban plasma levels and EXTEM CT and EXTEM CT ratios were superior to agreement between argatroban plasma levels and aPTT in the Bland Altman analysis. MCF remained unchanged during therapy with both drugs. CONCLUSION: In critically ill patients, TT and ROTEM parameters may provide better correlation to argatroban and lepirudin plasma concentrations than aPTT. TRIAL REGISTRATION: ClinicalTrials.gov , NCT00798525 , registered on 25 Nov 2008.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Zusammenfassung
Sub-study of the ALicia RCT in 35 critically ill HIT-suspect patients found rotational thromboelastometry (ROTEM CT) and thrombin time correlate better with argatroban/lepirudin plasma concentrations than the conventional aPTT, which performed poorly in this population.
Warum dies für die Hirudotherapie relevant ist
Diese Substudie der doppelblinden randomisierten ALicia-Studie analysierte Blut von 35 kritisch kranken Patienten, die Argatroban oder Lepirudin wegen Verdacht auf Heparin-induzierte Thrombozytopenie erhielten, und verglich aPTT, Thrombinzeit und ROTEM-Parameter mit den Plasmakonzentrationen der Wirkstoffe. Der Hauptbefund war, dass die aPTT nicht signifikant mit den Plasmakonzentrationen eines der beiden Wirkstoffe korrelierte, während Thrombinzeit und ROTEM-Parameter (INTEM CT, EXTEM CT) signifikante Korrelationen zeigten, was darauf hindeutet, dass diese bei kritisch kranken Patienten ein besseres Monitoring bieten könnten. Der Abstract beschreibt nicht die Beziehung von Lepirudin zu Hirudin und erwähnt keine Blutegel. Für die ASH ist die Verbindung zur Hirudotherapie durch den Abstract nicht etabliert; die Studie diskutiert Lepirudin rein als direkten Thrombininhibitor in einer bescheiden großen Substudienpopulation.
Zitation
Monitoring of argatroban and lepirudin anticoagulation in critically ill patients by conventional laboratory parameters and rotational thromboelastometry - a prospectively controlled randomized double-blind clinical trial.
Beiderlinden M et al. · BMC Anesthesiology, 2018
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