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

Sponsor
Michael Sander (Other)
Overall Status
Terminated
CT.gov ID
NCT01402739
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
46
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
  • Other: standard coagulation monitoring guided transfusion algorithm
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
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
Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: PoC algorithm guided transfusions

experimental arm

Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
(thromboelastometry, aggregometry, blood gas analysis)
Other Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. chest tube output [24 hours]

    Secondary Outcome Measures

    1. need of allogeneic blood transfusions [24 hours]

    2. course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT) [24 hours]

    3. duration of mechanical ventilation [hours (average)]

    4. incidence of RRT [during 30 days]

      or until hospital discharge, whatever is earlier

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Sander, Univ.-Prof. M. Sander, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01402739
    Other Study ID Numbers:
    • HEART-PoC
    First Posted:
    Jul 26, 2011
    Last Update Posted:
    Jun 15, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Michael Sander, Univ.-Prof. M. Sander, Charite University, Berlin, Germany
    PoC
    ROTEM
    Multiplate
    transfusion
    cardiac surgery
    drainage blood loss
    chest tube output
    Additional relevant MeSH terms:
    Hemorrhage

    Study Results

    No Results Posted as of Jun 15, 2015