Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01468597
First received: October 4, 2011
Last updated: June 2, 2014
Last verified: June 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BARC bleeding [ Time Frame: until postoperative day 2 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Emergent cardiac surgery

Detailed Description:

Blood for measuring platelet function is drawn before induction of anesthesia

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01468597     History of Changes
Other Study ID Numbers: 21-202 ex 09/10
Study First Received: October 4, 2011
Last Updated: June 2, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014