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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study

NCT01826123

Coagulopathy During Cardiac Surgery

UNKNOWN NA

POC - Transfusion Algorithm Cardiac Study

NCT02200419

Heart Diseases

COMPLETED NA

Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures

NCT00646373

Cardiac Surgery

TERMINATED NA

Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

NCT04369443

Cardiac Surgery Acute Normovolemic Hemodilution

COMPLETED NA

Perioperative Transfusion Strategies in Adult Congenital Heart Disease Patients Undergoing Cardiac Surgery

NCT04973514

Congenital Heart Disease Cardiac Surgery Blood Transfusion +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chest Tube Output Allogeneic Blood Transfusions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PoC algorithm guided transfusions

experimental arm

Group Type EXPERIMENTAL

Point of Care Coagulation Monitoring Guided Transfusion Algorithm

Intervention Type OTHER

(thromboelastometry, aggregometry, blood gas analysis)

standard of care transfusions

control arm

Group Type ACTIVE_COMPARATOR

standard coagulation monitoring guided transfusion algorithm

Intervention Type OTHER

aPTT, ACT, platelet count, hemoglobin, fibrinogen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Point of Care Coagulation Monitoring Guided Transfusion Algorithm

(thromboelastometry, aggregometry, blood gas analysis)

Intervention Type OTHER

standard coagulation monitoring guided transfusion algorithm

aPTT, ACT, platelet count, hemoglobin, fibrinogen

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ROTEM delta, Multiplate, ABL 725

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No