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

This study has been terminated.
(Study terminated prematurely due to futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402739
First Posted: July 26, 2011
Last Update Posted: June 15, 2015
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.
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • chest tube output [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: August 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01402739


Locations
Germany
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
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

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
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: June 15, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes