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Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468597
First Posted: November 9, 2011
Last Update Posted: January 27, 2015
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.
Information provided by (Responsible Party):
Medical University of Graz
  Purpose
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
Bleeding

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

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

Secondary Outcome Measures:
  • 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.


Enrollment: 161
Study Start Date: January 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
One group
Emergency surgery

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
Criteria

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%
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01468597


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01468597     History of Changes
Other Study ID Numbers: 21-202 ex 09/10
First Submitted: October 4, 2011
First Posted: November 9, 2011
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Medical University of Graz:
Emergent
Cardiac surgery
On-pump
Platelet function

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes