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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helfried Metzler, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01606865
First received: May 24, 2012
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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
Postoperative Bleeding

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • increased risk of bleeding (according to TIMI definition) [ Time Frame: 24hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: September 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
elective and acute non-cardiac surgery

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  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: NCT01606865

Locations
Austria
Department of Anesthesiology and Intensive Care Medicine, Medical University Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Study Chair: Helfried Metzler, Prof. Dr. Medical University of Graz
  More Information

No publications provided

Responsible Party: Helfried Metzler, MD, Prof., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01606865     History of Changes
Other Study ID Numbers: BIANCA
Study First Received: May 24, 2012
Last Updated: October 22, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 23, 2014