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Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00516126
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : January 11, 2013
Sponsor:
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).

Condition or disease
Coronary Artery Bypass Graft Triple Vessel Blood Coagulation Disorders

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors
Study Start Date : June 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Point-of-Care managed
This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)
Conventional hemostasis lab managed
This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Perioperative blood loss [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma [ Time Frame: 24 hours and 7 days ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac surgery
Criteria

Inclusion Criteria:

  • written consent

Exclusion Criteria:

  • no written consent
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00516126


Locations
Switzerland
University Hospital Basel
Basel, CH, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Miodrag Filipovic, PhD, MD Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00516126     History of Changes
Other Study ID Numbers: 194/06
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Daniel Bolliger, University Hospital, Basel, Switzerland:
hemostasis monitoring
perioperative blood loss

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
 Cardiovascular Diseases
Hemorrhagic Disorders
Hemostatics
Coagulants