Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446354
• Other study ID #: 347/10
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: October 23, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Anesthesia and Intensive Care Medicine	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion of allogeneic blood products		within 24 hours including surgery	No
Secondary	Proportion of patients without allogeneic blood products		24 hours including surgery	No
Secondary	Adverse events	Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration	within 24 hours including surgery	Yes