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Regulatory · 04 of 05

ISTH publishes guidance on factor concentrates for perioperative bleeding

Nothing from the drug regulators today; the ISTH has published guidance on factor concentrates in perioperative bleeding, worth reading against your own transfusion protocol rather than in place of it.

No drug approvals or safety communications for this desk in today's sweep. What did publish is guidance from the ISTH Scientific and Standardization Committee subcommittee on perioperative and critical care thrombosis and haemostasis, covering the use of factor concentrates for managing perioperative bleeding.

This is the territory where practice varies most and evidence is thinnest: prothrombin complex concentrate, fibrinogen concentrate and recombinant factors are used in bleeding theatres on a mixture of local protocol, availability and precedent. Guidance from the ISTH SSC is not a regulatory approval and carries no force, but it is the body most rheumatologically placed to say what the haemostasis evidence supports.

Worth reading alongside your own transfusion service's protocol rather than instead of it. Factor concentrate availability, cost and the presence or absence of point-of-care viscoelastic testing differ enough between institutions that a recommendation which is straightforward in one theatre is unimplementable in the next.

In Indian practice, where fibrinogen concentrate is often unavailable and cryoprecipitate remains the working substitute, the useful reading is the reasoning about thresholds rather than the product recommendations themselves.

  • Read it against your own transfusion protocol; availability differs enough to change what is implementable.
  • Where fibrinogen concentrate is unavailable, take the thresholds and the reasoning rather than the product.
  • SSC guidance is a consensus position, not a regulatory action — it carries no force.
  • No drug approvals or recalls affecting anaesthesia in today's sweep.

The statistics, in plain English

SSC guidance documents summarise evidence and expert consensus; they do not report a trial and carry no effect size. The thing to look for when reading one is where it distinguishes recommendation from suggestion, because in perioperative haemostasis much of the evidence base is observational and the strength of wording is doing the work that a confidence interval would do elsewhere.

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