NCT01468597

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 emergent 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
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

June 18, 2020

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

3.6 years

First QC Date

October 4, 2011

Results QC Date

March 9, 2020

Last Update Submit

June 17, 2020

Conditions

Bleeding

Keywords

EmergentCardiac surgeryOn-pumpPlatelet function

Outcome Measures

Primary Outcomes (1)

  • Calculated Blood Loss

    until postoperative day 5

Secondary Outcomes (1)

  • BARC Bleeding

    until postoperative day 2

Study Arms (1)

One group

Emergency surgery

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients needing emergent cardiac surgery under dual antiplatelet therapy

You may qualify if:

  • First time on-pump CABG with or without valve replacement

You may not qualify if:

  • Redo surgery,
  • Renal insufficiency needing dialysis,
  • Concomitant medication with warfarin,
  • Preoperative fibrinogen \< 150 mg%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

  • Mahla E, Prueller F, Farzi S, Pregartner G, Raggam RB, Beran E, Toller W, Berghold A, Tantry US, Gurbel PA. Does Platelet Reactivity Predict Bleeding in Patients Needing Urgent Coronary Artery Bypass Grafting During Dual Antiplatelet Therapy? Ann Thorac Surg. 2016 Dec;102(6):2010-2017. doi: 10.1016/j.athoracsur.2016.05.003. Epub 2016 Jul 1.

    PMID: 27378554DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Elisabeth Mahla, MD
Organization
Medical University of Graz
elisabeth.mahla@medunigraz.at
0043 316 385 13027

Study Officials

  • Elisabeth Mahla, M.D.

    Department of Anesthesia and Intensive Care Medicine, Medical University of Graz

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

November 9, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 18, 2020

Results First Posted

June 18, 2020

Record last verified: 2020-06

Locations

AU(1)