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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Bolliger, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00516126
First received: August 13, 2007
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Perioperative blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma [ Time Frame: 24 hours and 7 days ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 13, 2007
Last Updated: January 10, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016