Control of Anticoagulation
DRAFT Subcommittee Minutes
23 July 2011
08:00-12:00
Room B-1
Chairman: Trevor Patrick Baglin (UK)
Co-chairmen: Walter Ageno (IT), Job Harenberg (DE), Clive Kearon (CA), John Olson (US), Gualtiero Palareti (IT), Sam Schulman (CA)
Introduction and update on activities:
Current Active SSC Registries
1) Recurrent venous thromboembolism in anticoagulated patients with cancer
Sam Schulman, Anna Falanga
Nil to report from meeting. Update to follow.
2) Splanchnic vein thrombosis
Walter Ageno, Francisco Dentali, Sam Schulman
Enrollment commenced June 2008. Web-based registry. Planned sample size 550. Number recruited 574. 32 centres from 11 countries. Baseline data on 94% of patients. Completed 2 year follow up on 27.5%.
3) Cerebral vein thrombosis
Walter Ageno
Nil to report from meeting. Update to follow.
Planned new SSC Registries / Working Parties
None.
Current SSC Standardization Projects
1) Performance requirements of Point-of-Care monitors
AMHP van den Besselaar. Nil to report from meeting. Update to follow.
2) A working party to delineate methodology/endpoints/harmonization of present and future studies on perioperative AC management and bridging therapy
Alex Spyropoulos. The proposals for methodology and harmonization were presented at the meeting by Dr Spyropoulos. A written recommendation will be submitted to the committee for approval and subsequent submission for publication.
3 Evaluation (Standardisation) of tests to evaluate effect of factor Xa inhibitors (rivaroxaban)
Completed. Dr Job Harenberg presented the results of a multicentre evaluation of assays undertaken on behalf of the SSC using plasmas spiked with rivaroxaban between 50 and 750ng/ml One PT assay, 4 chromogenic anti-Xa assays and the Prothrombin induced clotting time were evaluated. No APTT assay was evaluated. CVs were reported for each assay. It is proposed that the results of the evaluation will be available through the website and the report may be published independent of the SSC as an original article.
4) Evaluation (Standardisation) of tests to evaluate effect of factor IIa inhibitors (dbigatran)
Dr Elaine Gray outlined a multicentre evaluation of assays undertaken on behalf of the SSC using plasmas spiked with dabigatran.
Planned SSC Standardization Projects
1) Evaluation (Standardisation) of tests to evaluate effect of factor Xa inhibitors (apixaban) This is to be considered before being formally proposed. Action: Chairman (Dr T Baglin).
SSC Publications in Past Year
1) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients - Schulman S, Angeras, Bergqvist, Eriksson, Lassen, Fisher. J Thromb Haemost. 2010;8:202-204
2) Reporting prothrombin time results as International Normalised Ratios for patients with chronic liver disease - Tripodi, Baglin, Robert, Kitchen, Lisman, Trotter. J Thromb Haemost. 2010;8:1410-12
3) International Collaborative Study for the calibration of a proposed international standard for thromboplastin, human, plain - Tripodi, Chantarangkul, van den Besselaar, Witteveen, Hubbard. J Thromb Haemost. 2010;8:2066-8
4) Risk of recurrent venous thromboembolism after stopping treatment in cohort studies: recommendation for acceptable rates and standardizing reporting - Kearon, Iorio, Palareti. J Thromb Haemost. 2010;8:2313-5.
Planned SSC publications
1) Standardisation of platelet thrombography - a recommendation from the SSC Subcommittee for control of anticoagulation - JTH 2011; in press
2) Laboratory measurement of rivaroxaban and dabigatran
Several presentations at the meeting addressed the issue of measuring new oral anticoagulants. Three scenarios in which measurement might be needed were identified:
- Emergency admission when it is necessary to determine if patient is anticoagulated or not, e.g surgical admission requiring emergency surgery;
- Compliance, e.g. detection of drug
- Failure of treatment in relation to intensity of treatment, e.g. thrombosis occurring during treatment in obese patient where dose intensification may be indicated.
Drug-specific and scenario-specific tests may/will be required. It was agreed in the meeting in response to requests from participants that an official recommendation from the subcommittee was required as soon as possible, i.e. before the end of the year. Dr Trevor Baglin (chairman) will lead the project and submit a formal project submission.
Additional SSC Special Projects
None
Educational Activities
It is proposed that an education programme will be included at the next SSC meeting in Liverpool.
Items requiring 2011 SSC Approval (standards or publications)
None
SSC - Subcommittee for Control of Anticoagulation
The meeting was held on Sunday July 24th at 08.00 - 12.00. An update of activities was presented by the Chairman before the following presentations:
- SSC Registry Report: Splanchnic vein thrombosis WALTER AGENO
- Quality of anticoagulation control during VKA therapy: effects on risk of bleeding and treatment failure GUALTIERO PALARETI
- Interpretation and management of INR results from patients treated with VKA antagonists, a study among clinicians from 14 countries ANN-HELEN KRISTOFFERSEN
- How should INR calibrants be used? JOHN OLSON, STEVE KITCHEN
- Update on novel non-oral anticoagulants - including idraparinux, idrabiotoparinux HARRY BULLER
- SSC Project Report: Determination of anticoagulant effects of rivaraoxaban: towards a recommendation for assays JOB HARENBERG
- SSC Project Report: Determination of anticoagulant effects of dabigatran: towards a recommendation for assays ELAINE GRAY
- Effects of the oral, direct thrombin inhibitor dabigatran on commonly used coagulation assays TOMAS LINDAHL
- Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays ANDREAS HILLARP
- Systematic review of perioperative heparin bridging therapy: implications of harmonization of outcome definitions and bivariate endpointsALEX SPYROPOULOS
Presentations were followed by an open discussion to identify issues to be addressed either through official SSC recommendations or through the new Clinical Guidance Group. In addition to measurement of new oral anticoagulant drugs the issues identified were:
- Which patients should be treated with the new anticoagulants first?
- What to do in case of bleeding?
- How to try to assess/improve compliance.
- Follow up during treatment - when and by whom?
- Instructions and documents to be given to patients.
- Pharmacokinetics/dynamics / implications for bridging
- Influence of renal function and practical considerations
- Interactions with drugs/diet
- Different doses for different patients
- Side-effects
- Information (efficacy/safety) to be collected during treatment (for phase IV studies)
- Recommendations for the national regulatory agencies regarding the introduction of the NOAC in clinical practice and observational phase IV studies
The Chairman will send a proposal to the Clinical Guidance Committee for a consensus/position statement on clinical issues.
