Table 4.
Studies addressing ROTEM® thresholds used for diagnosis of trauma coagulopathies
| Study | Comparator | ROTEM® thresholds used | Accuracy of threshold Sensitivity/Specificity |
AUC | Key findings | |
|---|---|---|---|---|---|---|
| Rugeri 2006 [36] | PTR > 1.5 FIB < 1.0 g/L |
EXTEM CA15 = 32 mm FIBTEM A10 = 5 mm |
87 91 |
100 85 |
0.98 0.96 |
1 – Significant correlation between EXTEM CA15 < 32 mm and PT >1.5 (r = 0.66, p < 0.0001) and of FIBTEM CA10 < 5 mm and Fibrinogen <1.0 g/L (r = 0.85, p < 0.0001). 2 – EXTEM A15 = 32 and FIBTEM A10 = 5 mm had a higher sensitivity and specificity to detect PTr > 1.5 and fibrinogen <1.0 g/L |
| Levrat 2008 [37] | ELT < 90s | EXTEM MCF ≤ 18 mm LI30 ≤ 71 % APTEM MCF ↑by 7 % |
100 75 80 |
100 100 100 |
1.00 0.87 0.92 |
1 – MCF correlated well with ELT when compared with amplitude and CLI. 2 – HF patients exhibited greater ROTEM® abnormalities, lower INR, lower fibrinogen levels and were more severely injured (↑ ISS) compared to the control group (all p < 0.05) |
| Schochl 2009 [26] | No comparator | EXTEM and INTEM ML = 100 % | NA | NA | NA | 1 – Fulminant HF confirmed by complete clot lysis within 30 min by ROTEM® trace |
| Doran 2010 [25] | PT > 18 s aPTT > 38 s |
EXTEM MCF < 45 mm | NA | NA | NA | 1 – ROTEM® detected coagulation abnormalities in 64 % patients vs. 10 % detected by SCTs as compared to test reference ranges? (p = 0.0005). 2 – MCF < 45 mm in 100 % of MT patients |
| Davenport 2011 [41] | PTR > 1.2 | EXTEM CA5 ≤ 35 mm | 77 | NA | NA | 1 – EXTEM CA5 ≤ 35 mm detected coagulopathy with 77 % sensitivity and a false positive rate of 13 % |
| Tauber, 2011 [40] | INR > 1.5 aPTT > 50s |
EXTEM MCF < 45 mm | 72 | 76 | 0.83 | 1 - Prevalence of low fibrinogen, impaired fibrin polymerization and reduced MCF was 26 %, 30 %, and 22 %, respectively, higher than the prolonged INR (14 %) 2 – There was ↑ F1 + 2 and TAT and low AT levels, indicating ↑ thrombin formation among all patients |
| FIB < 1.5 g/L PLT < 100 × 103 |
FIBTEM MCF < 7 mm LI60 < 85 % |
86 79 |
71 78 |
0.89 0.84 |
||
| Schochl, 2011 [39] | PTI < 70 %, | EXTEM CT > 80s CFT > 159 s MCF < 50 mm |
NA | NA | 0.77 | 1 – Coagulopathy was characterized by abnormal values in most or all ROTEM® measurements as compared to reference range vs. SCT. 2 – Significantly low CA5-CA30 min, MCF in EXTEM, INTEM and FIBTEM assays in non survivors vs. survivors (p < 0.01) |
| aPTT > 35 s, PLT < 100 × 103 |
INTEM CT > 240 s CFT > 110 s MCF < 50 mm |
|||||
| FIB < 1.5 g/L | FIBTEM MCF < 9 mm | |||||
| Rourke 2012 [42] | FIB < 1.5 g/L | EXTEM CA5 < 36 mm FIBTEM CA5 < 9.5 mm |
53 78 |
87 70 |
NA NA |
1 – ROTEM® parameters correlated with fibrinogen level. 2 – Ex vivo fibrinogen administration reversed coagulopathy by ROTEM®. |
| Woolley 2012 [30] | PT > 1.5 | EXTEM CA5 < 32 mm EXTEM A10 < 40 mm |
96 100 |
58 70 |
NA NA |
1 – EXTEM MCF < 40 mm and interim values of EXTEM A5 and A10 predicted coagulopathy (A15: sensitivity/specificity of 96 %/58 % and for A10: sensitivity/specificity 100 %/70 %) |
| Hagemo 2015 [43] | INR > 1.2 | EXTEM CA5 < 37 mm FIBTEM CA5 < 8 mm |
NA NA |
NA NA |
0.79 0.80 |
1 – Highest ROTEM® AUC values were found for EXTEM CA5 and FIBTEM CA5 for detecting ACoTS 2 – EXTEM CA5 ≤ 37 mm had a detection rate of 66.3 % and FIBTEM CA ≤ 8 mm had a detection rate of 67.5 % of ACoTS |
Legend: aPTT activated partial thromboplastin time, AT antithrombin III, AUC area under curve, CA clot amplitude (measured at 5,10,15 min, etc.), CFT clot formation time, ER emergency room, ED Emergency department, ELT euglobin lysis time, F1 + 2 prothrombin complex, FC fibrinogen concentrate, EXTEM extrinsically activated test with tissue factor, FDP fibrin degradation products, FIB fibrinogen, FIBTEM fibrin-based extrinsically activated test with tissue factor and the platelet inhibitor cytochalasin D, GCS Glasgow Coma Scale, HF hyperfibrinolysis, HGB hemoglobin, INR international normalized ratio, HCT hematocrit, ISS injury severity score, LI30 lysis index at 30 min, MCF maximum clot firmness, ML maximum lysis, mm millimeter, MT massive transfusion, NA not available, NPV negative predictive value, OR operation room, PLT platelet, PPV positive predictive value, PT prothrombin time, PTR prothrombin ratio, s seconds, sen sensitivity, SLTs standard laboratory tests, spec specificity, TAT thrombin antithrombin complex, TBI traumatic brain injury