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Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses (HEART-PoC)

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ClinicalTrials.gov Identifier: NCT01402739
Recruitment Status : Terminated (Study terminated prematurely due to futility)
First Posted : July 26, 2011
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 26, 2011
Last Update Posted Date June 15, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
chest tube output [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • need of allogeneic blood transfusions [ Time Frame: 24 hours ]
  • course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT) [ Time Frame: 24 hours ]
  • duration of mechanical ventilation [ Time Frame: hours (average) ]
  • incidence of RRT [ Time Frame: during 30 days ]
    or until hospital discharge, whatever is earlier
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Official Title  ICMJE Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Brief Summary Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.
Detailed Description Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chest Tube Output
  • Allogeneic Blood Transfusions
Intervention  ICMJE
  • Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
    (thromboelastometry, aggregometry, blood gas analysis)
    Other Name: ROTEM delta, Multiplate, ABL 725
  • Other: standard coagulation monitoring guided transfusion algorithm
    aPTT, ACT, platelet count, hemoglobin, fibrinogen
Study Arms  ICMJE
  • Experimental: PoC algorithm guided transfusions
    experimental arm
    Intervention: Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
  • Active Comparator: standard of care transfusions
    control arm
    Intervention: Other: standard coagulation monitoring guided transfusion algorithm
Publications * Lehmann F, Rau J, Malcolm B, Sander M, von Heymann C, Moormann T, Geyer T, Balzer F, Wernecke KD, Kaufner L. 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. BMC Anesthesiol. 2019 Feb 18;19(1):24. doi: 10.1186/s12871-019-0689-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2015)
100
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
116
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • elective cardiac surgery patient requiring cardiopulmonary bypass
  • moderate or high transfusion risk
  • signed informed consent

Exclusion Criteria:

  • age <18 or >80 years
  • known hemophilia
  • known thrombophilia
  • known thrombocytopathy
  • hereditary or acquired coagulation disorder
  • active endocarditis
  • ejection fraction <30%
  • BSA < 1.8 sqm
  • planned aortic arch surgery
  • preoperative thrombocytopenia <150/nl
  • underlying hemostaseological disease
  • preoperative anemia
  • liver cirrhosis Child B or higher
  • preoperative creatinine > 2mg/dl
  • terminal renal insufficiency requiring dialysis
  • vitamin k antagonists during 5 days prior to surgery
  • pregnant or breast-feeding women
  • known allergy against allogeneic blood products or coagulation factors
  • refusal of blood transfusions
  • any concomitant investigational agent or participation in another trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01402739
Other Study ID Numbers  ICMJE HEART-PoC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Sander, Charite University, Berlin, Germany
Study Sponsor  ICMJE Michael Sander
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Sander, MD Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Study Chair: Claudia D Spies, MD Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP