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Completed

NCT Number: NCT01446354

Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

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.

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Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Department of Anesthesia and Intensive Care Medicine

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Transfusion of allogeneic blood products

    Time frame: within 24 hours including surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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