Trial reportBMC anesthesiology2018
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.
Trial report in BMC anesthesiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00798525 (Argatroban Versus Lepirudin in Critically Ill Patients - A Randomized Double-blind Trial), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Argatroban Versus Lepirudin in Critically Ill Patients - A Randomized Double-blind Trial
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Anticoagulation Monitoring and Targets: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2024Pooled it
- Prognostic factors for patients with heparin-induced thrombocytopenia: a systematic review.International journal of clinical pharmacy · 2021Pooled it
- Review of the Current Issues Surrounding Monitoring of the Direct Thrombin Inhibitor Argatroban in the Laboratory.International journal of laboratory hematology · 2026Review
- An Overview of Anticoagulant Drugs Pharmacology, Therapeutic Approaches, Limitations and Perspectives.Pharmaceutics · 2026Review
- Production and functional characteristics of a novel hirudin variant with better anticoagulant activities than bivalirudin.Journal of enzyme inhibition and medicinal chemistry · 2025Article
- [Point of care coagulation diagnostics-Absolutely necessary or only a reasonable supplement?]Die Anaesthesiologie · 2025Review
- Anticoagulation in venovenous extracorporeal membrane oxygenation.Frontiers in medicine · 2025Review
- The impact of heparin and direct thrombin inhibitors on cell-penetrating polymer siRNA transfection.Gene therapy · 2024Article
- Article
- Anticoagulation Strategies during Extracorporeal Membrane Oxygenation: A Narrative Review.Journal of clinical medicine · 2022Review
- Transjugular intrahepatic portosystemic shunt, local thrombaspiration, and lysis for management of fulminant portomesenteric thrombosis and atraumatic splenic rupture due to vector-vaccine-induced thrombotic thrombocytopenia: a case report.Journal of medical case reports · 2022Article
- "In Less than No Time": Feasibility of Rotational Thromboelastometry to Detect Anticoagulant Drugs Activity and to Guide Reversal Therapy.Journal of clinical medicine · 2022Review
- The Composition and Physical Properties of Clots in COVID-19 Pathology.Diagnostics (Basel, Switzerland) · 2022Review
- Case Report: Hypergranular Platelets in Vaccine-Induced Thrombotic Thrombocytopenia After ChAdOx1 nCov-19 Vaccination.Frontiers in cardiovascular medicine · 2022Article
- Superior outcomes with Argatroban for heparin-induced thrombocytopenia: a Bayesian network meta-analysis.International journal of clinical pharmacy · 2021Review
- The role of rotational thromboelastometry during the COVID-19 pandemic: a narrative review.Korean journal of anesthesiology · 2021Review
- Falsely Low Fibrinogen Levels in COVID-19 Patients on Direct Thrombin Inhibitors.Anesthesia and analgesia · 2020Article
- Point-of-Care Diagnostics in Coagulation Management.Sensors (Basel, Switzerland) · 2020Review
- Monitoring of Argatroban and Lepirudin: What is the Input of Laboratory Values in "Real Life"?Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundArgatroban 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.
methodsThis 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.
resultsTo 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.
conclusionIn critically ill patients, TT and ROTEM parameters may provide better correlation to argatroban and lepirudin plasma concentrations than aPTT.
trial registrationClinicalTrials.gov , NCT00798525 , registered on 25 Nov 2008.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.