• G N Pike, A M Cumming, J Thachil, Hay C R M CRM Department of Haematology, Manchester Royal Infirmary, Central Manchester University Hospital NHS Trust, Manchester, UK. , Bolton-Maggs P H B PHB The University of Manchester, Manchester, UK. SHOT Office, Manchester Blood Centr, and J Burthem.
• Department of Haematology, Manchester Royal Infirmary, Central Manchester University Hospital NHS Trust, Manchester, UK.
• Haemophilia. 2017 May 1; 23 (3): 449-457.

IntroductionThe absence of a reliable clinical test to predict bleeding tendency leaves factor XI (FXI)-deficient individuals at risk of overtreatment or under treatment.AimTo assess whether rotational thromboelastometry has value in detection of FXI deficiency and identification of bleeding tendency.MethodsThromboelastometry was measured in whole blood and platelet-rich plasma (PRP) samples containing corn trypsin inhibitor (CTI) from controls (n = 50) and FXI-deficient individuals (n = 93) at tissue factor (TF) 0.12 pm. The effect of tissue plasminogen activator was also assessed. For analysis, FXI-deficient individuals were divided into bleeders (n = 24) and non-bleeders (n = 44) based on experience of tonsillectomy and/or dental extraction prior to diagnosis.ResultsIn whole blood, thromboelastometry distinguished those with major FXI deficiency (FXI:C ≤ 15 IU dL-1 ) but not partial deficiency from control populations, but did not identify bleeding phenotype. In PRP, bleeders had significantly longer clot formation time [CFT; 434 ± 179 s vs. 277 ± 70 s (mean ± SD); P < 0.05] and smaller α angle [43.8 ± 9.5° vs. 52.4 ± 5.8° (mean ± SD); P < 0.05] compared to non-bleeders. However, these parameters were found to depend on multiple additional variables and on an individual basis, ROC analysis showed test specificity for bleeding phenotype identification to be only 38.5% at 100% sensitivity: CFT (area under first derivative curve: AUC = 0.8091, P = 0.0014), α angle (AUC = 0.7804, P = 0.006).ConclusionThromboelastometry in PRP with CTI samples triggered with TF 0.12 pm was able to distinguish between bleeders and non-bleeders in FXI deficiency, but poor specificity restricts its clinical application as a test to identify bleeding phenotype. Further technical advances to the assay may allow better discrimination.© 2017 John Wiley & Sons Ltd.

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