Viscoelastic point of care (POC) tests for the diagnostic test accuracy (DTA) for the identification of hypofibrinogenaemia ROTEM (n= 1692); TEG (n= 128).
Comparison
Laboratory standard.
Outcome
There were no high quality studies of the DTA of viscoelastic POC tests for the identification of hypofibrinogenaemia in cardiac surgical patients. All the 9 DTA studies included had a risk of bias in relation to patient selection, flow and timing of the tests, or blinding of test results. Viscoelastic POC identification of hypofibrinogenaemia, when compared to laboratory fibrinogen measurement was associated with high false positive rates. The studies performed so far report false positive rates of up to 58%, but low false negative rates.
Abstract
Hypofibrinogenaemia during cardiac surgery may increase blood loss and bleeding complications. Viscoelastic point-of-care tests provide more rapid diagnosis than laboratory measurement, allowing earlier treatment. However, their diagnostic test accuracy for hypofibrinogenaemia has never been reviewed systematically. We aimed to systematically review their diagnostic test accuracy for the identification of hypofibrinogenaemia during cardiac surgery. Two reviewers assessed relevant articles from seven
electronic databases, extracted data from eligible articles and assessed quality. The primary outcomes were sensitivity, specificity and positive and negative predictive values. A total of 576 articles were screened and 81 full texts were assessed, most of which were clinical agreement or outcome studies. Only 10 diagnostic test accuracy studies were identified and only nine were eligible (ROTEMdelta 7; TEG5000 1; TEG6S 1, n = 1820 patients) (ROTEM, TEM International GmbH, Munich, Germany; TEG, Haemonetics, Braintree, MA, USA). None had a low risk of bias. Four ROTEM studies with a fibrinogen threshold less than 1.5-1.6 g/l and FIBTEM threshold A10 less than 7.5-8 mm had point estimates for sensitivity of 0.61-0.88; specificity 0.54-0.94; positive predictive value 0.42-0.70; and negative predictive value 0.74-0.98 (i.e. false positive rate 30%-58%; false negative rate 2%-26%). Two ROTEM studies with higher thresholds for both fibrinogen (<2 g/l) and FIBTEM A10 (<9.5 mm) had similar false positive rates (25%-46%), as did the two TEG studies (15%-48%). This review demonstrates that there have been few diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia in cardiac surgical patients. The studies performed so far report false positive rates of up to 58%, but low false negative rates. Further diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia are required to guide their better use during cardiac surgery.
