Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446354
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : October 24, 2012
Information provided by (Responsible Party):
Daniel Bolliger, 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.

Condition or disease
Cardiac Arrest

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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Cardiac surgery with HCA
Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta

Primary Outcome Measures :
  1. Transfusion of allogeneic blood products [ Time Frame: within 24 hours including surgery ]

Secondary Outcome Measures :
  1. Proportion of patients without allogeneic blood products [ Time Frame: 24 hours including surgery ]
  2. Adverse events [ Time Frame: within 24 hours including surgery ]
    Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446354

University Hospital Basel, Department of Anesthesia and Intensive Care Medicine
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Daniel Bolliger, PD Dr. University Hospital, Basel, Switzerland

Responsible Party: Daniel Bolliger, Principal Investigator, University Hospital, Basel, Switzerland Identifier: NCT01446354     History of Changes
Other Study ID Numbers: 347/10
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

Keywords provided by Daniel Bolliger, University Hospital, Basel, Switzerland:
Blood component transfusion

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms