Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study

F Lehmann, J Rau, B Malcolm, M Sander, C von Heymann, T Moormann, T Geyer, F Balzer, K D Wernecke, L Kaufner, F Lehmann, J Rau, B Malcolm, M Sander, C von Heymann, T Moormann, T Geyer, F Balzer, K D Wernecke, L Kaufner

Abstract

Background: Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Timely diagnostic and goal-directed therapies aim at the reduction of bleeding and need for allogeneic transfusions.

Methods: Single-centre, prospective, randomized trial assessing blood loss and transfusion requirements of 26 adult patients undergoing elective cardiac surgery at high risk for perioperative bleeding. Primary endpoint was blood loss at 24 h postoperatively. Random assignment to intra- and postoperative haemostatic management following either an algorithm based on conventional coagulation assays (conventional group: platelet count, aPTT, PT, fibrinogen) or based on point-of-care (PoC-group) monitoring, i.e. activated rotational thromboelastometry (ROTEM®) combined with multiple aggregometry (Multiplate®). Differences between groups were analysed using nonparametric tests for independent samples.

Results: The study was terminated after interim analysis (n = 26). Chest tube drainage volume was 360 ml (IQR 229-599 ml) in the conventional group, and 380 ml (IQR 310-590 ml) in the PoC-group (p = 0.767) after 24 h. Basic patient characteristics, results of PoC coagulation assays, and transfusion requirements of red blood cells and fresh frozen plasma did not differ between groups. Coagulation results were comparable. Platelets were transfused in the PoC group only.

Conclusion: Blood loss via chest tube drainage and transfusion amounts were not different comparing PoC- and central lab-driven transfusion algorithms in subjects that underwent high-risk cardiac surgery. Routine PoC coagulation diagnostics do not seem to be beneficial when actual blood loss is low. High risk procedures might not suffice as a sole risk factor for increased blood loss.

Trial registration: NCT01402739 , Date of registration July 26, 2011.

Keywords: Algorithms; Blood coagulation; Blood transfusion; Point-of-care systems; Thoracic surgery.

Conflict of interest statement

Ethics approval and consent to participate

The study was conducted at the Department of Anaesthesiology and Intensive Care Medicine of Charité - University Medicine Berlin, Berlin, Germany in adherence to the latest version of the declaration of Helsinki, approved by the local Ethics Board (Ethics Committee of Charité - University Medicine Berlin (EA1/263/10). All patients gave written informed consent prior to entering the study.

Consent for publication

Not applicable.

Competing interests

JR, BM, TM, and TG have no conflicts of interest. KDW received honoraria from Charité - University Medicine Berlin related to the topic of this study. LK received honoraria for lectures related to the topic of this work as well as travel reimbursements from CSL Behring, NovoNordisk GmbH, TEM International, Sinetica and HICC GbR. CvH received honoraria for lectures and consultancy work related to the topic of this work as well as travel reimbursements from CSL Behring, Ferring GmbH, NovoNordisk GmbH, Haemonetics and HICC GbR. FL received travel reimbursements from Edwards Lifesciences. FB received grants, personal fees and/or non-financial supports from Einstein Foundation, Axon Publishing, Clearflow, Vifor Pharma and Medtronic. MS received grants from Medtronic, Edwards Lifesciences, AMOMED, Fisher&Peykel, Grünenthal, Massimo and Gettinge Group.

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Figures

Fig. 1
Fig. 1
PoC therapy algorithms for the PoC group in case of blood loss exceeding 1.5 ml/kg body weight (kgBW)/hour in two consecutive hours or 4 ml/kgBW/hour for at least 30 min, or bleeding delaying chest closure intraoperatively. a Activated rotational thromboelastometry (ROTEM®)-based haemostatic management algorithm. b Multiple electrode aggregometry (MEA)-based haemostatic management algorithm
Fig. 2
Fig. 2
Consort flow-chart
Fig. 3
Fig. 3
Cumulative chest tube drainage volume of the first 24 h postoperatively. Multivariate nonparametric analysis of longitudinal data in a two-factorial design (1st factor: groups, 2nd factor: repetitions in time) revealed no differences between conventional and point-of-care group (p = 0.548)

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