Clinical trial NCT01402739: Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Official title: Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chest Tube Output
Allogeneic Blood Transfusions
Keywords: PoC
ROTEM
Multiplate
transfusion
cardiac surgery
drainage blood loss
chest tube output
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: chest tube output
timeFrame: 24 hours
Secondary outcomes:
measure: need of allogeneic blood transfusions
timeFrame: 24 hours
measure: course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
timeFrame: 24 hours
measure: duration of mechanical ventilation
timeFrame: hours (average)
measure: incidence of RRT
timeFrame: during 30 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Study officials:
affiliation: Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
name: Michael Sander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
name: Claudia D Spies, MD
role: STUDY_CHAIR
References:
citation: Lehmann F, Rau J, Malcolm B, Sander M, von Heymann C, Moormann T, Geyer T, Balzer F, Wernecke KD, Kaufner L. Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study. BMC Anesthesiol. 2019 Feb 18;19(1):24. doi: 10.1186/s12871-019-0689-7.