Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery
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Purpose
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 |
|---|
|
Cardiac Arrest |
| Study Type: | Observational |
| Study Design: | 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 |
- Transfusion of allogeneic blood products [ Time Frame: within 24 hours including surgery ] [ Designated as safety issue: No ]
- Proportion of patients without allogeneic blood products [ Time Frame: 24 hours including surgery ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: within 24 hours including surgery ] [ Designated as safety issue: Yes ]Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration
| Enrollment: | 200 |
| Study Start Date: | January 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Cardiac surgery with HCA
Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
- none
Contacts and Locations| Switzerland | |
| University Hospital Basel, Department of Anesthesia and Intensive Care Medicine | |
| Basel, BS, Switzerland, 4031 | |
| Principal Investigator: | Daniel Bolliger, PD Dr. | University Hospital, Basel, Switzerland |
More Information
No publications provided
| Responsible Party: | Daniel Bolliger, Principal Investigator, University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01446354 History of Changes |
| Other Study ID Numbers: | 347/10 |
| Study First Received: | September 29, 2011 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
Blood component transfusion Hypothermic |
Additional relevant MeSH terms:
|
Heart Arrest Hypothermia Heart Diseases |
Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013