Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery

Postoperative Bleeding Clinical Trial

— BIANCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606865
• Other study ID #: BIANCA
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: October 22, 2014
• Start date: September 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Bleeding
• Postoperative Hemorrhage

Locations

Country	Name	City	State
Austria	Department of Anesthesiology and Intensive Care Medicine, Medical University Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increased risk of bleeding (according to TIMI definition)		24hours postoperatively	No