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

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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

Tracking Information
First Submitted Date March 8, 2018
First Posted Date March 29, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date January 1, 2011
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2018)
Transfusion requirement [ Time Frame: Postoperative hospital stay; on average 8 days ]
RBC-Red Blood Cells (units), FFP-Fresh Frozen Plasma (units), PLT-Platelets (units)
Original Primary Outcome Measures
 (submitted: March 22, 2018)
Transfusion requirement [ Time Frame: Postoperative hospital stay; on average 8 days ]
All blood products
Change History
Current Secondary Outcome Measures
 (submitted: March 22, 2018)
  • Postoperative complications [ Time Frame: Postoperative hospital stay; on average 8 days ]
    Infections, myocardial infarction, cerebrovascular insult, acute renal failure
  • Mortality [ Time Frame: Postoperative hospital stay; on average 8 days ]
    Death
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Transfusion and Postoperative Outcome Before and After Implementing a Coagulation Management Algorithm
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
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.

Detailed Description

Patient data and all relevant procedure related data of cardiac surgery procedures at the Triemli City Hospital, Switzerland are recorded in a dedicated database with the approval of the institutional research ethics board and patient informed consent. Data analysis focusing on coagulation management using a dedicated algorithm in the present quality control study is done for 1754 out of 2199 consecutive patients undergoing cardiac surgery comprising the initial cohort from 2009 to 2011 (before implementation of the algorithm) and the subsequent cohort from 2013 to 2015 (after implementation of the algorithm).

In the time period analyzed for this study anesthesia and intensive care were performed according to standardized protocols. Fluid management was done with lactated Ringer's solution and synthetic colloids. Different blood conservation strategies were used and included consistently cell salvage, standardized application of tranexamic acid and retrograde autologous cardiopulmonary bypass (CPB) priming. Anticoagulant medication was suspended at least 5 days prior to surgery for all elective procedures. Hematocrit measurements were performed using a standard POC blood gas analyzer available in the OR. Indication for red blood cells (RBC) transfusion were a hematocrit (HCT) level below 21% during CPB, below 25% for patients with preserved left ventricular function and 28% for patients with a left ventricular function ≤ 30% and patients undergoing emergency procedures. Standard laboratory tests (blood count, international normalized ratio (INR) / prothrombin time (PT), activated partial thromboplastin time (aPTT) fibrinogen concentration (FIB) were routinely available for guiding transfusion of coagulation blood products. Coagulation management before the implementation of the algorithm was performed based on institutional guidelines in accordance with published recommendations. Kaolin activated clotting time (ACT) measurements were used to guide heparin and protamine management. After heparin reversal and ongoing bleeding prothrombin complex concentrate was applied at a PT ≤ 70% / INR threshold of 1.5 and in selected cases with ongoing major bleeding fresh frozen plasma (FFP) was used to normalize PT/INR. Moreover, fibrinogen concentrate was given below a fibrinogen level of 1 g/l. Platelet concentrates (PLT) were transfused when platelet count was ≤ 100 x 109/lit. PLT were also given in suspected platelet dysfunction. When severe bleeding occurred at the end of the surgical procedure coagulation management was started on an empirical basis by the anesthesiologist in charge.

The SONOCLOT coagulation management algorithm is based on existing literature on this subject and the experience of the authors with the specific POC technique: It considers standard coagulation lab results and platelet function tests and includes the use of the MULTIPLATE analyzer. SONOCLOT measurements consist basically of three dedicated tests:

  1. A kaolin ACT that is being applied for heparin and protamine administration.
  2. A glass-bead ACT providing information about the initiation of the clotting process, the propagation of the coagulation and platelet function.
  3. A glass-bead ACT with heparinase in case the measurement has to be performed under heparin.

First coagulation measurements in each patient undergoing cardiac surgery are executed in the pre-intervention period. The established baseline values trigger the preparation of coagulation blood products that will be applied in the post-interventional period. At the end of the surgical procedure, heparin reversal is performed according to the Bulls protocol. After initial antagonisation with protamine kaolin ACT and glass-bead ACT as well as a heparinase glass-bead ACT are done to primarily detect any residual heparin. For any registered serum heparin the treatment and measurement loop is repeated. In case of an ongoing bleeding after heparin reversal a surgery-related cause has to be excluded and then another treatment and management loop based on glass-bead ACT is initiated and repeated until coagulation has been restored. As soon as results of the standard lab test are available in the postoperative period these are included in the decision making process.

Primary outcome parameters were transfusion rates during the operation and the treatment in the ICU. Secondary outcome parameters included morbidity: an mortality in the postoperative period during the hospital stay.

Statistical analysis will be performed with the software package R. To compare patient-related demographic and perioperative data prior and post algorithm implementation and univariable analysis are performed. Based on the data format and distribution, either Fisher's exact test, t-tests or Wilcoxon rank sum test were applied. For the assessment of the difference of transfusion in the two cohorts and controlling potential influence of other factors two approaches have been chosen. First, after a continuity-corrected log-transformation of the units of RBC given, a sequence of preoperative and procedure related predictors were included in the analysis. To check for multi-colinearity, variance inflation factors are assessed with the R package. Furthermore, to assess the association between potential risk factors and the incidence of postoperative infections a generalized linear model with a binomial link and logit function was chosen and performed with the R package.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients undergoing cardiac surgery at the Triemli City Hospital
Condition Coagulation Disorder, Blood
Intervention
  • 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
Study Groups/Cohorts
  • preAlgorithm
    Standard coagulation management of patients undergoing cardiac surgery
    Intervention: Device: Standard coagulation management
  • postAlgorithm
    Coagulation management guided by SONOCLOT of patients undergoing cardiac surgery
    Intervention: Device: Coagulation management guided by SONOCLOT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2018)
1754
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03482128
Other Study ID Numbers STZ-Dendrite11-15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Christoph K Hofer, Triemli Hospital
Study Sponsor Triemli Hospital
Collaborators University of Zurich
Investigators
Study Chair: Michele Genoni, MD, Prof Triemli City Hospital
PRS Account Triemli Hospital
Verification Date May 2018