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

Conditions

Allogeneic Blood Transfusions, Chest Tube Output

Keywords

PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output

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 .

F. Lehmann, J Rau, Bianca Malcolm, Michael Sander, Christian von Heymann et al. (10 authors)

BMC Anesthesiology2019-02-1821 citations

10.1186/s12871-019-0689-7

Interventions

OTHERPoint of Care Coagulation Monitoring Guided Transfusion Algorithm

(thromboelastometry, aggregometry, blood gas analysis)

OTHERstandard coagulation monitoring guided transfusion algorithm

aPTT, ACT, platelet count, hemoglobin, fibrinogen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
chest tube output	24 hours

Secondary

Measure	Time frame	Description
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	during 30 days	or until hospital discharge, whatever is earlier

Countries

Germany

Outcome results

None listed