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Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery (BIANCA)

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. Identifier: NCT01606865
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : October 23, 2014
Information provided by (Responsible Party):
Helfried Metzler, MD, Medical University of Graz

Brief Summary:
The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.

Condition or disease
Postoperative Bleeding

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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy
Study Start Date : September 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

elective and acute non-cardiac surgery

Primary Outcome Measures :
  1. increased risk of bleeding (according to TIMI definition) [ Time Frame: 24hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days

Inclusion Criteria:

  • intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
  • spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)

Exclusion Criteria:

  • concomitant medication with warfarin
  • renal insufficiency needing dialysis
  • concomitant therapy with GPIIB/IIIA Antagonists
  • expected duration of operation >30min

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 identifier (NCT number): NCT01606865

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Department of Anesthesiology and Intensive Care Medicine, Medical University Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Study Chair: Helfried Metzler, Prof. Dr. Medical University of Graz
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Responsible Party: Helfried Metzler, MD, Prof., Medical University of Graz Identifier: NCT01606865    
Other Study ID Numbers: BIANCA
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications