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

This study is currently recruiting participants.
Verified December 2012 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01402739
First received: July 25, 2011
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Chest Tube Output
Allogeneic Blood Transfusions
 Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
Other: standard coagulation monitoring guided transfusion algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • chest tube output [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • need of allogeneic blood transfusions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • duration of mechanical ventilation [ Time Frame: hours (average) ] [ Designated as safety issue: No ]
  • incidence of RRT [ Time Frame: during 30 days ] [ Designated as safety issue: No ]
    or until hospital discharge, whatever is earlier


Estimated Enrollment: 116
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PoC algorithm guided transfusions
experimental arm
 Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
(thromboelastometry, aggregometry, blood gas analysis)
Other Name: ROTEM delta, Multiplate, ABL 725
Active Comparator: standard of care transfusions
control arm
 Other: standard coagulation monitoring guided transfusion algorithm
aPTT, ACT, platelet count, hemoglobin, fibrinogen

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402739

Contacts
Contact: Michael Sander, MD +49 30 450 531 ext 012 michael.sander@charite.de
Contact: Christian von Heymann, MD +49 30 450 551 ext 102 christian.von_heymann@charite.de

Locations
Germany
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Michael Sander, MD     +49 30 450 531 ext 052     michael.sander@charite.de    
Principal Investigator: Michael Sander, MD            
Sub-Investigator: Juliane Rau            
Sub-Investigator: Stephanie Scholz            
Sub-Investigator: Katharina Berger, MD            
Sponsors and Collaborators
Michael Sander
Investigators
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
  More Information

No publications provided

Responsible Party: Michael Sander, Univ.-Prof. M. Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01402739     History of Changes
Other Study ID Numbers: HEART-PoC
Study First Received: July 25, 2011
Last Updated: December 17, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
PoC
ROTEM
Multiplate
transfusion
 cardiac surgery
drainage blood loss
chest tube output

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013