NCT01606865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

3.3 years

First QC Date

May 24, 2012

Last Update Submit

October 22, 2014

Conditions

Postoperative Bleeding

Outcome Measures

Primary Outcomes (1)

  • increased risk of bleeding (according to TIMI definition)

    24hours postoperatively

Study Arms (1)

elective and acute non-cardiac surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Medical University Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Helfried Metzler, Prof. Dr.

    Medical University of Graz

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

September 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 23, 2014

Record last verified: 2014-10

Locations

AU(1)