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

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses

Conditions
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Chest Tube Output, Allogeneic Blood Transfusions

Intervention / Treatment
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* Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm
* Other: standard coagulation monitoring guided transfusion algorithm


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PoC algorithm guided transfusions<br>experimental arm | Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm<br>* (thromboelastometry, aggregometry, blood gas analysis)<br>* Other names: ROTEM delta, Multiplate, ABL 725;|
| Active Comparator: standard of care transfusions<br>control arm | Other: standard coagulation monitoring guided transfusion algorithm<br>* aPTT, ACT, platelet count, hemoglobin, fibrinogen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest tube output |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need of allogeneic blood transfusions |  | 24 hours | 
| course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT) |  | 24 hours | 
| duration of mechanical ventilation |  | hours (average) | 
| incidence of RRT | or until hospital discharge, whatever is earlier | during 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output