Trial Outcomes & Findings for Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery (NCT NCT01468597)

NCT ID: NCT01468597

Last Updated: 2020-06-18

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 167 participants
• Primary outcome timeframe: until postoperative day 5
• Results posted on: 2020-06-18

Participant Flow

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.

Participant milestones

Measure	One Group Emergency surgery
Overall Study STARTED	184
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure	One Group Emergency surgery
Overall Study Found ineligible	17
Overall Study concomitant valves	12
Overall Study off-pump CABG	1
Overall Study no platelet function data	5

Baseline Characteristics

Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

Baseline characteristics by cohort

Measure	One Group n=149 Participants Emergency surgery
Age, Continuous	68.2 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	149 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Austria	149 participants n=5 Participants

PRIMARY outcome

Timeframe: until postoperative day 5

Outcome measures

Measure	One Group n=149 Participants Emergency surgery
Calculated Blood Loss	1996 milliters Interval 937.0 to 1572.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	One Group n=149 Participants Emergency surgery
BARC Bleeding	72 participants

Adverse Events

One Group

Serious events: 13 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Measure	One Group n=149 participants at risk Emergency surgery
General disorders Mortality	8.7% 13/149 • Number of events 13

Other adverse events

Adverse event data not reported

Additional Information

Elisabeth Mahla, MD

Medical University of Graz

Phone: 0043 316 385 13027

Email: elisabeth.mahla@medunigraz.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place