ArticleBritish journal of clinical pharmacology2006
Effects of the direct thrombin inhibitor dabigatran on ex vivo coagulation time in orthopaedic surgery patients: a population model analysis.
Article in British journal of clinical pharmacology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 115 citations in OpenAlex.
- Quantitative analysis of efficacy and associated factors of calcium intake on bone mineral density in postmenopausal women.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017Pooled it
- Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review.Chest · 2017Pooled it
- [Dealing with massive bleeding and associated perioperative coagulopathy: recommendations for action of the German Society of Anaesthesiology and Intensive Care Medicine].Der Anaesthesist · 2013Guideline
- A semi-mechanistic absorption model to evaluate drug-drug interaction with dabigatran: application with clarithromycin.British journal of clinical pharmacology · 2013Trial
- Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.Clinical pharmacokinetics · 2008Trial
- Central Composite Design-Optimized Dabigatran Etexilate Cubosomes for Sustained Oral Release and Enhanced In Vivo Pharmacokinetics.Pharmaceutical research · 2026Article
- Examining the Reliability of Model-Based Meta-Analysis (MBMA) Outcomes: A Simulation Study.CPT: pharmacometrics & systems pharmacology · 2026Article
- Antiplatelet, Anticoagulant, and Fibrinolytic Activity of Orchids: A Review.Molecules (Basel, Switzerland) · 2024Review
- Delayed concentration effect models for dabigatran anticoagulation.Paediatric anaesthesia · 2022Article
- Updates on Anticoagulation and Laboratory Tools for Therapy Monitoring of Heparin, Vitamin K Antagonists and Direct Oral Anticoagulants.Biomedicines · 2021Review
- Clinical Management of Pharmacokinetic Drug Interactions with Direct Oral Anticoagulants (DOACs).Drugs · 2019Review
- Interrupting anticoagulation in patients with nonvalvular atrial fibrillation.P & T : a peer-reviewed journal for formulary management · 2014Article
- Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants.Journal of the American College of Cardiology · 2014Review
- Potential use of NOACs in developing countries: pros and cons.European journal of clinical pharmacology · 2014Review
- A clinician's perspective: novel oral anticoagulants to reduce the risk of stroke in nonvalvular atrial fibrillation--full speed ahead or proceed with caution?Vascular health and risk management · 2014Review
- The role of prothrombin complex concentrates in reversal of target specific anticoagulants.Thrombosis journal · 2014Review
- Extracorporeal therapy for dabigatran removal in the treatment of acute bleeding: a single center experience.Clinical journal of the American Society of Nephrology : CJASN · 2013Article
- Dabigatran in the peri-procedural period for radiofrequency ablation of atrial fibrillation: efficacy, safety, and impact on duration of hospital stay.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2013Observational
- Dabigatran and kidney disease: a bad combination.Clinical journal of the American Society of Nephrology : CJASN · 2013Review
- Measuring the anticoagulant effects of target specific oral anticoagulants-reasons, methods and current limitations.Journal of thrombosis and thrombolysis · 2013Review
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo describe the pharmacokinetic-pharmacodynamic (PK-PD) characteristics of the direct thrombin inhibitor dabigatran in hip replacement patients by assessing coagulation parameters activated partial thromboplastin time (aPTT) and ecarin clotting time (ECT), interindividual variability and factors affecting PD responses.
methodsBISTRO I patients received oral dabigatran etexilate postsurgery for 6-10 days. Dabigatran plasma concentrations and aPTT/ECT were measured on the day of surgery, on subsequent days and at steady state. PK-PD characteristics of the dabigatran-aPTT/ECT relationships were evaluated using NONMEM V.
resultsThe dabigatran concentration-aPTT relationship was described combining a linear and an E(max) model. Mean baseline aPTT was 33.4 s and E(max) (maximum increase in aPTT contributed by the E(max) model) was 26.9 s. The dabigatran concentration needed to attain 50% of maximum effect (EC(50)) was 94.7 ng ml(-1) and the mean slope of the linear concentration-response relationship (SLOP) was 0.0509 s ng(-1) ml(-1). Baseline aPTT and E(max) were highest following surgery and declined with time. The dabigatran concentration-ECT relationship fitted a linear model. Mean baseline ECT was 28 s and decreased with time; 50% of the maximum effect was observed after 2.9 days. SLOP decreased from 0.38 to 0.27 s ng(-1) ml(-1) with a half-life of 1.1 day, indicating greater PD effects on the day of surgery. Interindividual and residual variability was low. Covariates could not explain variability of this model.
conclusionsaPTT and ECT prolongation were directly correlated with dabigatran concentrations. Blood coagulation prolongation was most pronounced following surgery. Data suggest that ECT provides a more precise description of the anticoagulant effect than aPTT.
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