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

October 22, 2014 updated by: Helfried Metzler, MD, Medical University of Graz

Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Department of Anesthesiology and Intensive Care Medicine, Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
elective and acute non-cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increased risk of bleeding (according to TIMI definition)
Time Frame: 24hours postoperatively
24hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Study Chair: Helfried Metzler, Prof. Dr., Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (Estimate)

May 28, 2012

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIANCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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