Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

NCT ID: NCT01446354

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Keywords

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Blood component transfusion Hypothermic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiac surgery with HCA

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Daniel Bolliger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Bolliger, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel, Department of Anesthesia and Intensive Care Medicine

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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347/10

Identifier Type: -

Identifier Source: org_study_id