Goal 2: Reduce Human Disease

Viscoelastic vs traditional coagulation tests as a guide to hemostatic treatments

Does the use of viscoelastic testing to guide plasma transfusion improve outcomes when compared to traditional coagulation testing?

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Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? : Compelling Question (CQ)

Details on the impact of addressing this CQ or CC :

The PT/INR are frequently used to guide hemostatic interventions, particularly in the ICU where the risk for hemorrhage is increased. In part, this is the result of long standing misconceptions regarding the relationship between PT/INR values with in vivo coagulation factor concentrations and clinical coagulation or hemostasis. Indeed, this misinformation almost certainly contributes to the well-documented inappropriate use of plasma products. To this point, it has now been demonstrated in a variety of clinical settings that the PT/INR is often poorly predictive of clinical coagulopathy or peri-procedural bleeding complications.

 

The last decade has seen a resurgence of interest in viscoelastic tests as alternatives assessments of hemostasis and guides to blood component use. Indeed, a body of literature supports the potential value of these tests in specific clinical settings. However, the value of such testing strategies has not been well described in the setting of the intensive care unit. Ongoing equipoise regarding the optimal assessment of coagulation status in the ICU suggests that a well conducted trial in this domain would have the potential to be truly transformative.

Feasibility and challenges of addressing this CQ or CC :

The assessment of coagulation status and decisions related to plasma transfusion occurs multiple times throughout the day in essentially every intensive care unit across the US. Therefore, an adequately sized study population is clearly present and therefore, a multicenter trial is feasible with NHLBI support.

 

A potential challenge with a study evaluating the optimal coagulation testing strategy is the incomplete penetration of viscoelastic testing in current clinical practice raising concerns related to the resource and educational requirements if such a trial were pursued. Additionally, viscoelastic testing can take several forms, each of which may impose specific confounders. Therefore, specific technologies and transfusion algorithms would likely need to be employed.

 

Importantly, innovative trial designs may also help us to address some of the feasibility concerns noted above. One such design that may prove valuable in this setting is the stepped-wedge cluster randomization design. Implementation of such a design might be expected to improve investigator/clinician cooperation/compliance and may help reduce treatment group contamination.

Name of idea submitter and other team members who worked on this idea : Daryl J. Kor, MD and Walter H. Dzik, MD for the 2015 NHLBI State of the Science in Transfusion Medicine.

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Idea No. 409