OC 15.2 - ROTEM versus conventional coagulation parameter based correction of coagulopathy in upper gastrointestinal bleed in cirrhotic patients - Open label randomized control trial

Background: Conventional tests of hemostasis, PT or aPTT, assess only plasmatic events in hemostasis omitting the contribution of the platelet scaffold and interactions with other cellular components of whole blood. These tests may provide an inadequate and misleading assessment of bleeding risk in patients with liver disease. In contrast, viscoelastic testing (VET) provides an overall assessment of hemostasis covering contributions both from plasmatic and cellular components. While globally, VET has become a cornerstone for blood component management, developing nations still fall back upon the conventional tests of hemostasis. We aimed to assess efficacy and cost effectiveness of Rotational Thromboelsatometry (ROTEM) in guiding blood component therapy in upper gastrointestinal (UGI) bleed in cirrhotic patients.

Aims: Assess the efficacy of ROTEM in guiding the correction of coagulopathy in cirrhotic patients with UGI bleed (Variceal and non-Variceal bleed) and impaired traditional coagulation tests.

Methods: Patients with biopsy proven cirrhosis and presenting with UGI bleed were enrolled into the study, and randomly assigned to ROTEM or to Standard-of-Care (SOC) group. Depending on the test findings in each arm, blood were transfused with aim to have correction of test abnormalities by repeat testing at 12 hours, and subsequently once daily for 5 days as well as clinical-based primary outcome.

Results: A total of 140 patients were evaluated over last 18 months; Male: Female ratio was 7.23:1.The group in the ROTEM arm received significantly fewer blood components and had fewer adverse events related to transfusion therapy with only a marginal increase in costs of testing. The increased cost was compensated by the reduced blood component usage and less management costs for adverse events in the ROTEM arm.

Conclusion(s): Use of VET to guide hemostatic support was shown to be better than conventional hemostasis testing for correction of coagulopathy in upper gastrointestinal bleed in cirrhotic patients.