Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medical University of Graz
First received: October 4, 2011
Last updated: June 2, 2014
Last verified: June 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Blood for measuring platelet function is drawn before induction of anesthesia
|Ages Eligible for Study:
||30 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients needing emergent cardiac surgery under dual antiplatelet therapy
- First time on-pump CABG with or without valve replacement
- Redo surgery,
- Renal insufficiency needing dialysis,
- Concomitant medication with warfarin,
- Preoperative fibrinogen < 150 mg%
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01468597
|Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz
|Graz, Austria, 8036 |
Medical University of Graz
||Elisabeth Mahla, M.D.
||Department of Anesthesia and Intensive Care Medicine, Medical University of Graz
No publications provided
||Medical University of Graz
History of Changes
|Other Study ID Numbers:
||21-202 ex 09/10
|Study First Received:
||October 4, 2011
||June 2, 2014
||Austria: Federal Office for Safety in Health Care
Keywords provided by Medical University of Graz:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014