Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses (HEART-PoC)

Michael Sander

Status: Terminated

Conditions: Allogeneic Blood Transfusions; Chest Tube Output

Treatments: Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm; Other: standard coagulation monitoring guided transfusion algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01402739

HEART-PoC

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PoC algorithm guided transfusions

Experimental group

Description:

experimental arm

Treatment:

Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm

standard of care transfusions

Active Comparator group

Description:

control arm

Treatment:

Other: standard coagulation monitoring guided transfusion algorithm