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

Allogeneic Blood Transfusions Clinical Trial

— HEART-PoC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01402739
• Other study ID #: HEART-PoC
• Status: Terminated
• Phase: N/A
• First received: July 25, 2011
• Last updated: June 12, 2015
• Start date: August 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allogeneic Blood Transfusions
• Chest Tube Output
• Hemorrhage

Intervention

Other:
• Point of Care Coagulation Monitoring Guided Transfusion Algorithm
(thromboelastometry, aggregometry, blood gas analysis)
• standard coagulation monitoring guided transfusion algorithm
aPTT, ACT, platelet count, hemoglobin, fibrinogen

Locations

Country	Name	City	State
Germany	Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Michael Sander

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chest tube output		24 hours	Yes
Secondary	need of allogeneic blood transfusions		24 hours	Yes
Secondary	course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)		24 hours	No
Secondary	duration of mechanical ventilation		hours (average)	No
Secondary	incidence of RRT	or until hospital discharge, whatever is earlier	during 30 days	No