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

NCT03482128 | Completed FDA Device

• 1 other identifier: STZ-Dendrite11-15
• Study Type: observational
• Target: 1,754
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transfusion; coagulation; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Transfusion requirement

  RBC-Red Blood Cells (units), FFP-Fresh Frozen Plasma (units), PLT-Platelets (units)

  Postoperative hospital stay; on average 8 days

Secondary Outcomes (2)

• Postoperative complications

  Postoperative hospital stay; on average 8 days

• Mortality

  Postoperative hospital stay; on average 8 days

Study Arms (2)

preAlgorithm

Standard coagulation management of patients undergoing cardiac surgery

Device: Standard coagulation management

postAlgorithm

Coagulation management guided by SONOCLOT of patients undergoing cardiac surgery

Device: Coagulation management guided by SONOCLOT

Interventions

Coagulation management guided by SONOCLOT DEVICE

Application of blood products guided by SONOCLOT measurements

postAlgorithm

Standard coagulation management DEVICE

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

preAlgorithm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing cardiac surgery at the Triemli City Hospital

You may qualify if:

• Patients undergoing cardiac surgery at the Triemli City Hospital
• Coronary artery bypass grafting
• Valve intervention (Aortic/Mitral/Tricuspid)
• Aortic surgery
• Time period before implementation of a coagulation management guided by SONOCLOT
• Time period after implementation of a coagulation management guided by SONOCLOT

You may not qualify if:

• Time period during implementation of a coagulation management guided by SONOCLOT
• Missing data in data base

Sponsors & Collaborators

• Triemli Hospital: lead
• University of Zurich: collaborator

Study Sites (1)

Triemli City Hospital

Zurich, 8063, Switzerland

Location

Related Publications (3)

• Serraino GF, Murphy GJ. Routine use of viscoelastic blood tests for diagnosis and treatment of coagulopathic bleeding in cardiac surgery: updated systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):823-833. doi: 10.1093/bja/aex100.

  PMID: 28475665 BACKGROUND

• Deppe AC, Weber C, Zimmermann J, Kuhn EW, Slottosch I, Liakopoulos OJ, Choi YH, Wahlers T. Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res. 2016 Jun 15;203(2):424-33. doi: 10.1016/j.jss.2016.03.008. Epub 2016 Mar 26.

  PMID: 27363652 BACKGROUND

• Whiting P, Al M, Westwood M, Ramos IC, Ryder S, Armstrong N, Misso K, Ross J, Severens J, Kleijnen J. Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2015 Jul;19(58):1-228, v-vi. doi: 10.3310/hta19580.

  PMID: 26215747 BACKGROUND

MeSH Terms

Conditions

Blood Coagulation Disorders; Thrombosis

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michele Genoni, MD, Prof

  Triemli City Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: March 29, 2018
• Study Start: January 1, 2011
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)