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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00516126

First Posted: August 14, 2007

Last Update Posted: January 11, 2013

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.

Information provided by (Responsible Party):

Daniel Bolliger, University Hospital, Basel, Switzerland

Purpose

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	Phase
Coronary Artery Bypass Graft Triple Vessel Blood Coagulation Disorders	Phase 4


Study Type:	Observational
Study Design:	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

Further study details as provided by Daniel Bolliger, University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Perioperative blood loss [ Time Frame: 24 hours ]

Secondary Outcome Measures:

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


Enrollment:	200
Study Start Date:	June 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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)

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	August 13, 2007
First Posted:	August 14, 2007
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

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