Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

Does the Intraoperative Thromboelastometry-guided Coagulation Management Reduce the Administration of Allogeneic Blood Products in Cardiac Surgery With the Help of Hypothermic Cardiac Arrest? A Retrospective Data Analysis

Sponsors

Lead Sponsor: University Hospital, Basel, Switzerland

Source University Hospital, Basel, Switzerland
Brief Summary

Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

Detailed Description

The investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of HCA from January 2009 to June 2011.

The investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. In addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

Overall Status Completed
Start Date January 2011
Completion Date February 2012
Primary Completion Date December 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Transfusion of allogeneic blood products within 24 hours including surgery
Secondary Outcome
Measure Time Frame
Proportion of patients without allogeneic blood products 24 hours including surgery
Adverse events within 24 hours including surgery
Enrollment 200
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011

Exclusion Criteria:

- none

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Daniel Bolliger, PD Dr. Principal Investigator University Hospital, Basel, Switzerland
Location
Facility: University Hospital Basel, Department of Anesthesia and Intensive Care Medicine
Location Countries

Switzerland

Verification Date

October 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital, Basel, Switzerland

Investigator Full Name: Daniel Bolliger

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Cardiac surgery with HCA

Description: Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta

Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov