Thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion

Background Severe bleeding and coagulopathy as a result of massive transfusion are serious clinical conditions that are associated with high mortality. Thromboelastography (TEG) and thromboelastometry (ROTEM) are increasingly used to guide transfusion strategy but their roles remain disputed. Objectives To systematically assess the benefits and harms of a TEG or ROTEM guided transfusion strategy in randomized trials involving patients with severe bleeding. Search strategy Randomized clinical trials (RCTs) were identified from electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 9); MEDLINE; EMBASE; Science Citation Index Expanded; International Web of Science; CINAHL; LILACS; and the Chinese Biomedical Literature Database (up to 31st October 2010). We contacted trial authors, authors of previous reviews, and manufacturers in the field. Selection criteria We included all RCTs, irrespective of blinding or language, that compared transfusion guided by TEG or ROTEM to transfusion guided by clinical judgement and standard laboratory tests, or both. Data collection and analysis Two authors independently abstracted data; they resolved any disagreements by discussion. We presented pooled estimates of the intervention effects on dichotomous outcomes as relative risks (RR) and on continuous outcomes as mean differences, with 95% confidence intervals (CI). Our primary outcome measure was all cause mortality. We performed subgroup and sensitivity analyses to assess the effect of TEG or ROTEM in adults and children on various clinical and physiological outcomes. We assessed the risk of bias through assessment of trial methodological components and the risk of random error through trial sequential analysis. Main results We included nine RCTs with a total of 776 participants; only one trial had a low risk of bias. We found two ongoing trials but were unable to retrieve any data from them. Compared with standard treatment, TEG or ROTEM showed no statistically significant effect on overall mortality (3.78% versus 5.11%, RR 0.77, 95% CI 0.35 to 1.72; I-2 = 0%) but only five trials provided data on mortality. Our analyses demonstrated a statistically significant effect of TEG or ROTEM on the amount of bleeding (MD -85.05 ml, 95% CI -140.68 to -29.42; I-2 = 26%) but failed to show any statistically significant effect on other predefined outcomes. Authors' conclusions There is an absence of evidence that TEG or ROTEM improves morbidity or mortality in patients with severe bleeding. Application of a TEG or ROTEM guided transfusion strategy seems to reduce the amount of bleeding but whether this has implications for the clinical condition of patients is still uncertain. More research is needed.