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Response to rebuttal, definition of major bleeding in surgery: an anaesthesiologist's point of view.

Författare och institution:
S Schulman (-); Ulf Angerås (Institutionen för kliniska vetenskaper, sektionen för kirurgi och kirurgisk gastroforskning, Avdelningen för kirurgi); D Bergqvist (-); B Eriksson (-); M R Lassen (-); W Fisher (-)
Publicerad i:
Journal of thrombosis and haemostasis, 8 ( 6 ) s. 1443-1444
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
See also Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W. Definition of major bleeding in clinical investigations of anti-hemostatic medicinal products in surgical patients. J Thromb Haemost 2010; 8: 202–4; Rosencher N, Zufferey P, Samama C-M. Definition of major bleeding in surgery: an anesthesiologist's point of view: a rebuttal. This issue, pp 1442–3. We read with interest the comments by Rosencher et al. about our definition of major bleeding in surgical patients. The component of our definition that is the focus of this discussion is criterion 5, i.e. the unexpected bleeding with some additional requirements [1]. We are aware that anesthesiologists frequently make use of more detailed calculations of blood loss. Their way of calculating blood loss is certainly more accurate than the criterion of a defined drop in hemoglobin or the need for 2 or more units of blood transfusion. In theory, such calculations are physiologically relevant for the decision to give a blood transfusion and may, therefore, result in more appropriate and hopefully reduced use of blood transfusions as indicated in the OSTHEO study [2]. However, criteria that are based on blood loss calculations have never been used for recognition of major bleeding. One of us (B.E.) evaluated blood loss, transfusion requirement and delta-hemoglobin in phase II studies on desirudin and melagatran. These variables had a lower sensitivity than the surgeon’s subjective view of ’serious bleeding‘ or ’overt bleeding‘ in the dose response of these anticoagulants. There is thus insufficient evidence to propose that calculated blood loss could be superior to differentiate between drug-induced and surgical bleeding. The European Medicines Agency (EMEA) guideline from 2007 (printed 2008) [3] is the one we want to improve and correct with our set of definitions. That guideline primarily uses the criteria defined by ISTH for medical patients. As additional support, calculated blood loss is in the middle of a long list of examples. In our work with the ISTH guidelines, we have tried to consider the important factors for both the surgeon and the patient. At the same time, it was necessary to create a definition that could not only be applied to most types of surgery represented in clinical trials using new anticoagulants, but also to keep it comparatively simple. The fact that both European and North American orthopedic and general surgeons could agree on these criteria was a big step forward. Although we admit that criterion no. 5 remains partly subjective, we find that the criterion suggested by Rosencher et al., ’all abnormal bleeding notified by the local investigator‘ is highly subjective and susceptible to influence by the knowledge that the patient is taking part in a trial with a new hemostatic agent. In trials, the local investigator is frequently not the operating surgeon. Who better than the surgeon present in the operating theatre, can assess what is unexpected (for the circumstances) and what represents prolonged bleeding? Some of us have been members of multiple committees for central event-adjudication for these studies, and we have often found that advice from the surgeon is the most helpful for gauging the seriousness of the wound bleeding and any likely association to study drug rather than to other bleeding risk factors. We, therefore, feel that the ISTH guideline for surgical patients is workable, in line with standard clinical practice and acceptable in any multicenter trial. A completely scientific and evidence-based process to develop ideal guidelines should select different strict criteria and prospectively evaluate their sensitivity for clinically important outcomes, including long-term function.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Postens nummer:
Posten skapad:
2010-06-01 09:40
Posten ändrad:
2012-02-29 09:50

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