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Blood Transfusion and Postoperative Outcome Before and After Implementing a Coagulation Management Algorithm

NCT03482128 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1754

Last updated 2018-05-18

No results posted yet for this study

Summary

Implementing coagulation management algorithms based on Point-of-care (POC) testing devices such as thromboelastography (TEG) or rotational thromboelastometry (ROTEM) have been shown to reduce transfusion rates and the occurrence of adverse patient outcomes. Apart from the TEG and ROTEM, another viscoelastic POC measurement technique, the SONOCLOT, can be easily used at the bedsite. However Information regarding a SONOCLOT based coagulation management algorithm however is lacking.

Transfusion rates of allogeneic blood products (Red blood cells = RBC, Fresh frozen plasma = FFP, Platelet concentrates = PLT) and patient adverse outcomes in two cohorts before and after the implementation of a SONOCLOT based coagulation management algorithm were evaluated on an observational basis in 1754 patients undergoing different types of cardiac surgery. The effect of the cohort and 19 predictors on transfusion was assessed by relative R2-values obtained by bootstrapping and a hurdle regression model, comprising a binomial and a Poisson count component. Association of predictors with post-operative outcomes was assessed with a logistic regression model.

Conditions

  • Coagulation Disorder, Blood

Interventions

DEVICE

Coagulation management guided by SONOCLOT

Application of blood products guided by SONOCLOT measurements

DEVICE

Standard coagulation management

Application of blood products based on clinical experience of the anesthesiologist in charge

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Triemli Hospital

    lead OTHER

Principal Investigators

  • Michele Genoni, MD, Prof · Triemli City Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2015-12-31
Completion
2015-12-31
FDA Device
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482128 on ClinicalTrials.gov