- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402739
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses (HEART-PoC)
June 12, 2015 updated by: Michael Sander
Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
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 Overview
Status
Terminated
Conditions
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
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PoC algorithm guided transfusions
experimental arm
|
(thromboelastometry, aggregometry, blood gas analysis)
Other Names:
|
Active Comparator: standard of care transfusions
control arm
|
aPTT, ACT, platelet count, hemoglobin, fibrinogen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
chest tube output
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
need of allogeneic blood transfusions
Time Frame: 24 hours
|
24 hours
|
|
course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
Time Frame: 24 hours
|
24 hours
|
|
duration of mechanical ventilation
Time Frame: hours (average)
|
hours (average)
|
|
incidence of RRT
Time Frame: during 30 days
|
or until hospital discharge, whatever is earlier
|
during 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
July 25, 2011
First Submitted That Met QC Criteria
July 25, 2011
First Posted (Estimate)
July 26, 2011
Study Record Updates
Last Update Posted (Estimate)
June 15, 2015
Last Update Submitted That Met QC Criteria
June 12, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEART-PoC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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