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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482128
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Christoph K Hofer, Triemli Hospital

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.


Condition or disease Intervention/treatment
Coagulation Disorder, Blood Device: Coagulation management guided by SONOCLOT Device: Standard coagulation management

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Study Type : Observational
Actual Enrollment : 1754 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Allogeneic Blood Transfusion and Postoperative Outcome Before and After Implementing a SONOCLOT Based Coagulation Management Algorithm in Cardiac Surgery: A Quality Control Study
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
preAlgorithm
Standard coagulation management of patients undergoing cardiac surgery
Device: Standard coagulation management
Application of blood products based on clinical experience of the anesthesiologist in charge

postAlgorithm
Coagulation management guided by SONOCLOT of patients undergoing cardiac surgery
Device: Coagulation management guided by SONOCLOT
Application of blood products guided by SONOCLOT measurements




Primary Outcome Measures :
  1. Transfusion requirement [ Time Frame: Postoperative hospital stay; on average 8 days ]
    RBC-Red Blood Cells (units), FFP-Fresh Frozen Plasma (units), PLT-Platelets (units)


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: Postoperative hospital stay; on average 8 days ]
    Infections, myocardial infarction, cerebrovascular insult, acute renal failure

  2. Mortality [ Time Frame: Postoperative hospital stay; on average 8 days ]
    Death



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing cardiac surgery at the Triemli City Hospital
Criteria

Inclusion

  • 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

Exclusion

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482128


Locations
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Switzerland
Triemli City Hospital
Zurich, Switzerland, 8063
Sponsors and Collaborators
Triemli Hospital
University of Zurich
Investigators
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Study Chair: Michele Genoni, MD, Prof Triemli City Hospital

Publications:
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Responsible Party: Christoph K Hofer, Prof. Dr. med, Triemli Hospital
ClinicalTrials.gov Identifier: NCT03482128    
Other Study ID Numbers: STZ-Dendrite11-15
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Christoph K Hofer, Triemli Hospital:
transfusion
coagulation
cardiac surgery
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders