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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01402739 |
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Date of registration:
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25/07/2011 |
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Primary sponsor: |
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Public title:
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Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
HEART-PoC |
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Scientific title:
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Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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116 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01402739 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Michael Sander, MD |
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Address:
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Telephone:
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+49 30 450 531 |
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Email:
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michael.sander@charite.de |
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Affiliation:
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Name:
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Michael Sander, MD |
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Address:
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Telephone:
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+49 30 450 531 |
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Email:
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michael.sander@charite.de |
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Affiliation:
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Name:
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Claudia D Spies, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin |
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Name:
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Michael Sander, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allogeneic Blood Transfusions
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Chest Tube Output
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Intervention(s)
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Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
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Other: standard coagulation monitoring guided transfusion algorithm
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Primary Outcome(s)
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chest tube output
[Time Frame: 24 hours]
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Secondary Outcome(s)
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course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
[Time Frame: 24 hours]
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duration of mechanical ventilation
[Time Frame: hours (average)]
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incidence of RRT
[Time Frame: during 30 days]
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need of allogeneic blood transfusions
[Time Frame: 24 hours]
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Secondary ID(s)
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HEART-PoC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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