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

Not Applicable

Terminated

• Conditions: Chest Tube Output; Allogeneic Blood Transfusions
• Interventions: Other: standard coagulation monitoring guided transfusion algorithm; Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm

• Registration Number: NCT01402739
• Lead Sponsor: Michael Sander

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 .

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-08
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard of care transfusions	standard coagulation monitoring guided transfusion algorithm	control arm
PoC algorithm guided transfusions	Point of Care Coagulation Monitoring Guided Transfusion Algorithm	experimental arm

Primary Outcome Measures

Name	Time	Method
chest tube output	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany