Back to resultsAlgorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses (HEART-PoC)
Primary Purpose
Chest Tube Output, Allogeneic Blood Transfusions
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Point of Care Coagulation Monitoring Guided Transfusion Algorithm
standard coagulation monitoring guided transfusion algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Chest Tube Output focused on measuring PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output
Eligibility 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
Sites / Locations
- Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PoC algorithm guided transfusions
standard of care transfusions
Arm Description
experimental arm
control arm
Outcomes
Primary Outcome Measures
chest tube output
Secondary Outcome Measures
need of allogeneic blood transfusions
course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
duration of mechanical ventilation
incidence of RRT
or until hospital discharge, whatever is earlier
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01402739
Brief Title
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Acronym
HEART-PoC
Official Title
Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated prematurely due to futility
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Sander
4. Oversight
Data Monitoring Committee
No
5. 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Tube Output, Allogeneic Blood Transfusions
Keywords
PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PoC algorithm guided transfusions
Arm Type
Experimental
Arm Description
experimental arm
Arm Title
standard of care transfusions
Arm Type
Active Comparator
Arm Description
control arm
Intervention Type
Other
Intervention Name(s)
Point of Care Coagulation Monitoring Guided Transfusion Algorithm
Other Intervention Name(s)
ROTEM delta, Multiplate, ABL 725
Intervention Description
(thromboelastometry, aggregometry, blood gas analysis)
Intervention Type
Other
Intervention Name(s)
standard coagulation monitoring guided transfusion algorithm
Intervention Description
aPTT, ACT, platelet count, hemoglobin, fibrinogen
Primary Outcome Measure Information:
Title
chest tube output
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
need of allogeneic blood transfusions
Time Frame
24 hours
Title
course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
Time Frame
24 hours
Title
duration of mechanical ventilation
Time Frame
hours (average)
Title
incidence of RRT
Description
or until hospital discharge, whatever is earlier
Time Frame
during 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sander, MD
Organizational Affiliation
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia D Spies, MD
Organizational Affiliation
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
30777015
Citation
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.
Results Reference
derived
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Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
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