January 1, 2021Clinical and Applied Thrombosis/HemostasisOpen Access

The Evaluation of Hemostatic Abnormalities Using a CWA-Small Amount Tissue Factor Induced FIX Activation Assay in Major Orthopedic Surgery Patients

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Why the study?

The utility of a clot waveform analysis of small tissue factor induced FIX activation assay to monitor edoxaban efficacy in major orthopedic surgery patients needed analysis.

Does the CWA-sTF/FIXa assay reflect hemostatic abnormalities or predict clinical outcomes in major orthopedic surgery patients receiving edoxaban?

Structured PICO

Does the CWA-sTF/FIXa assay reflect hemostatic abnormalities or predict clinical outcomes in major orthopedic surgery patients receiving edoxaban?

Population

147 patients with major orthopedic surgery (109 total hip arthroplasty [THA] and 38 total knee arthroplasty [TKA]) receiving edoxaban for the prevention of venous thromboembolism (VTE)

Intervention

Clot waveform analysis (CWA) of small tissue factor induced FIX activation (sTF/FIXa) assay in platelet-rich plasma (PRP) and platelet-poor plasma (PPP)

Outcome

Utility of CWA-sTF/FIXa assay to reflect hemostatic abnormalities and monitor edoxaban efficacysurrogate

The CWA-sTF/FIXa assay reflects hemostatic changes post-orthopedic surgery and during edoxaban therapy, but does not significantly differentiate patients who develop DVT or massive bleeding.

Limitations

Further studies separately analyzing the THA and TKA subgroups should be conducted

Implication

CWA-sTF/FIXa does not distinguish DVT or bleeding risk post-orthopedic edoxaban; leaves open its predictive utility pending prospective validation.

Abstract

We analyzed the utility for a clot waveform analysis (CWA) of small tissue factor induced FIX activation (sTF/FIXa) assay in patients with major orthopedic surgery (including total hip arthroplasty [THA] and total knee arthroplasty [TKA]) receiving edoxaban for the prevention of venous thromboembolism (VTE). The sTF/FIXa assay using recombinant human TF in platelet-rich plasma (PRP) and platelet-poor plasma (PPP) was performed using a CWA in the above patients to monitor the efficacy of edoxaban administration. Of 147 patients (109 THA and 38 TKA), 21 exhibited deep vein thrombosis (DVT), and 15 had massive bleeding. Increased peak heights of the CWA-sTF/FIX were observed in almost patients after surgery and prolonged peak heights of the CWA-sTF/FIX were observed in almost patients treated with edoxaban. The peak heights and times of the CWA-sTF/FIX were significantly higher and shorter, respectively, in PRP than in PPP. There were no significant differences in parameters of the CWA-sTF/FIXa between the patients with and without DVT or between those with and without massive bleeding. The peak time of CWA-sTF/FIXa were significantly longer in TKA patients than in THA patients on day 1 after surgery. The second derivative peak height of the CWA-sTF/FIXa was significantly lower in TKA patients than in THA patients on day 4. The CWA-sTF/FIX reflected hemostatic abnormalities after surgery and the administration of edoxaban, and the results were better in PRP than PPP. Further studies separately analyzing the THA and TKA subgroups should be conducted.