Evaluation of children with a suspected bleeding disorder applying the Impact-R [Cone and Plate(let) Analyzer]

Background: A convenient screening test for children with bleeding symptoms before more labor-intensive diagnostic steps are taken would be of value. The Impact-R was designed in an attempt to analyse platelet function under near physiological conditions. Results are presented as surface coverage (SC, %) and average size (AS, μm ²). Objective: In this cross-sectional retrospective study, we assessed the use of the Impact-R in the evaluation of children with a suspected bleeding disorder (BD). Methods: The hospital charts of 110 children referred to the coagulation laboratory were reviewed for personal and family bleeding history (BH) as well as results of the laboratory evaluation. Results: A laboratory 'diagnosable' BD (LBD) was found in 23 children (21%, 95% CI 14-30%). A diagnosis of LBD was associated with the severity of bleeding but not with family BH. By receiver-operating characteristic (ROC) curve analysis, the SC was superior to the AS for diagnosis of a LBD. The Impact-R was abnormal in 43/97 children (44.3%, 95% CI 34-55%). The predictive values of a normal and abnormal Impact-R were 96% (95% CI 92-97%) and 42% (95% CI 28-56%), respectively. When considering the personal and family BH, the post-test probability for LBD after a normal Impact-R was reduced from 20% to 3.5% (95% CI 2.5-7%). Conclusions: A normal Impact-R test is highly effective in excluding LBDs. Yet, in case of an abnormal Impact-R test, further testing is needed. An algorithm that includes the personal and family BH and the results of a screening test may improve the diagnostic process. Prospective studies are now needed to confirm these findings.