Bleeding
Conditions
Keywords
Emergent, Cardiac surgery, On-pump, Platelet function
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.
Detailed description
Blood for measuring platelet function is drawn before induction of anesthesia
Interventions
None listed
Sponsors
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated Blood Loss | until postoperative day 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BARC Bleeding | 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. |
Countries
Austria
Participant flow
Pre-assignment details
184 patients were screened for eligibility. Of these, 17 patients were found to be ineligible for the study. Therefore the number of actually enrolled patients is 167.
Participants by arm
| Arm | Count |
|---|---|
| One Group Emergency surgery | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | concomitant valves | 12 |
| Overall Study | Found ineligible | 17 |
| Overall Study | no platelet function data | 5 |
| Overall Study | off-pump CABG | 1 |
Baseline characteristics
| Characteristic | One Group |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 149 Participants |
| Region of Enrollment Austria | 149 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 149 |
| other Total, other adverse events | 0 / 149 |
| serious Total, serious adverse events | 13 / 149 |
Outcome results
Primary
Calculated Blood Loss
Time frame: until postoperative day 5
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| One Group | Calculated Blood Loss | 1996 milliters |
Secondary
BARC Bleeding
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.
Time frame: until postoperative day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| One Group | BARC Bleeding | 72 participants |