Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01468597
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease

Detailed Description:
Blood for measuring platelet function is drawn before induction of anesthesia

Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study
Study Start Date : January 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

One group
Emergency surgery

Primary Outcome Measures :
  1. Calculated blood loss [ Time Frame: until postoperative day 5 ]

Secondary Outcome Measures :
  1. BARC bleeding [ Time Frame: until postoperative day 2 ]
    Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period.

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients needing emergent cardiac surgery under dual antiplatelet therapy

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01468597

Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Elisabeth Mahla, M.D. Department of Anesthesia and Intensive Care Medicine, Medical University of Graz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical University of Graz Identifier: NCT01468597     History of Changes
Other Study ID Numbers: 21-202 ex 09/10
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Medical University of Graz:
Cardiac surgery
Platelet function

Additional relevant MeSH terms:
Pathologic Processes