Trial Outcomes & Findings for STAT-STatin and Aspirin in Trauma (NCT NCT02901067)
NCT ID: NCT02901067
Last Updated: 2023-04-27
Results Overview
Based on screening duplex ultrasound (US) of legs and central line on day 5 or upon ICU discharge or upon symptoms of VTE (whichever comes first).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Day 5 or ICU discharge or upon symptoms of VTE (whichever comes first)
Results posted on
2023-04-27
Participant Flow
Total of 43 patients were enrolled. Four patients withdrew after signing the consent, 2 were not randomized (1 discharged from ICU before randomization occurred, 1 received aspirin per attending prescription, making the patient ineligible for randomization).
Participant milestones
| Measure |
Experimental
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
STAT-STatin and Aspirin in Trauma
Baseline characteristics by cohort
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 years
n=99 Participants
|
39.8 years
n=107 Participants
|
34.9 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Mechanism of injury
Blunt
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Mechanism of injury
Penetrating
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Injury Severity Score (ISS)
|
17 units on a scale
n=99 Participants
|
22 units on a scale
n=107 Participants
|
20 units on a scale
n=206 Participants
|
|
Field systolic blood pressure (SBP)
|
101 mmHg
n=99 Participants
|
90 mmHg
n=107 Participants
|
99 mmHg
n=206 Participants
|
|
Field heart rate (HR)
|
100 beats per minute (bpm)
n=99 Participants
|
98 beats per minute (bpm)
n=107 Participants
|
100 beats per minute (bpm)
n=206 Participants
|
|
Field shock index (SI)
|
1 units on a scale
n=99 Participants
|
0.9 units on a scale
n=107 Participants
|
1 units on a scale
n=206 Participants
|
|
Field Glasgow Coma Scale (GCS)
|
14 units on a scale
n=99 Participants
|
14.5 units on a scale
n=107 Participants
|
14 units on a scale
n=206 Participants
|
|
Admission lactate
|
4.9 mg/dL
n=99 Participants
|
5.5 mg/dL
n=107 Participants
|
5 mg/dL
n=206 Participants
|
|
Admission pH
|
7.3 units on a scale
n=99 Participants
|
7.3 units on a scale
n=107 Participants
|
7.3 units on a scale
n=206 Participants
|
|
Admission base excess
|
-7.2 mEq/L
n=99 Participants
|
-8.2 mEq/L
n=107 Participants
|
-7.8 mEq/L
n=206 Participants
|
|
Admission haemoglobin
|
15 g/dL
n=99 Participants
|
13.1 g/dL
n=107 Participants
|
14.2 g/dL
n=206 Participants
|
|
Admission platelet count
|
266 1000 cells/microL
n=99 Participants
|
230.5 1000 cells/microL
n=107 Participants
|
239 1000 cells/microL
n=206 Participants
|
|
Admission International normalized ratio (INR)
|
1.1 ratio
n=99 Participants
|
1.1 ratio
n=107 Participants
|
1.1 ratio
n=206 Participants
|
|
Admission partial thromboplastin time (PTT)
|
25 seconds
n=99 Participants
|
25.4 seconds
n=107 Participants
|
25.3 seconds
n=206 Participants
|
|
Admission fibrinogen
|
219 mg/dL
n=99 Participants
|
179 mg/dL
n=107 Participants
|
218 mg/dL
n=206 Participants
|
|
Admission D-dimer
|
5.8 mcg/mL
n=99 Participants
|
9 mcg/mL
n=107 Participants
|
9 mcg/mL
n=206 Participants
|
|
Red blood cell (RBC) transfusion within first 6 hours of admission
|
1 units
n=99 Participants
|
0 units
n=107 Participants
|
1 units
n=206 Participants
|
|
Fresh frozen plasma (FFP) transfusion within first 6 hours of admission
|
0 units
n=99 Participants
|
0 units
n=107 Participants
|
0 units
n=206 Participants
|
|
Platelet transfusion within first 6 hours of admission
|
0 units
n=99 Participants
|
0 units
n=107 Participants
|
0 units
n=206 Participants
|
|
Cryoprecipitate transfusion within first 6 hours of admission
|
0 units
n=99 Participants
|
0 units
n=107 Participants
|
0 units
n=206 Participants
|
|
Massive transfusion
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 5 or ICU discharge or upon symptoms of VTE (whichever comes first)Based on screening duplex ultrasound (US) of legs and central line on day 5 or upon ICU discharge or upon symptoms of VTE (whichever comes first).
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Incidence of VTE
|
0 percentage of patients
|
22 percentage of patients
|
SECONDARY outcome
Timeframe: During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hoursPopulation: We were unable to obtain samples at hour 6, as all patients were enrolled after 6 hours postinjury. The percentages below show the percentage of patients in fibrinolysis shutdown, the phenotype associated with increased risk of venous thromboembolism events.
Measured by traditional and tissue plasminogen activator (tPA) - Challenge thrombelastography (TEG) lysis at 30 minutes (LY30).
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Fibrinolysis Phenotypes
12 hours
|
0 percentage of patients
|
50 percentage of patients
|
|
Fibrinolysis Phenotypes
24 hours
|
43 percentage of patients
|
57 percentage of patients
|
|
Fibrinolysis Phenotypes
48 hours
|
25 percentage of patients
|
31 percentage of patients
|
|
Fibrinolysis Phenotypes
72 hours
|
33 percentage of patients
|
25 percentage of patients
|
|
Fibrinolysis Phenotypes
120 hours
|
38 percentage of patients
|
25 percentage of patients
|
|
Fibrinolysis Phenotypes
168 hours
|
33 percentage of patients
|
20 percentage of patients
|
SECONDARY outcome
Timeframe: During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hoursPopulation: we were unable to measure PAI-1 and tPA in the blood samples due to lack of funding to acquire the necessary reagents and test kits. Thus, no results were produced.
To be measured in platelet poor plasma (PPP)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within two weeks post-injuryPopulation: Acute lung injury (ALI) was defined as by the Berlin criteria.
Based on Berlin Criteria
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Incidence of Acute Lung Injury (ALI)
|
0 percentage of patients
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: All patients had this assessment. No missing data.
As measured by ventilator-free days (VFD). VFDs are typically defined as follows (1): VFDs = 0 if subject dies within 28 days of mechanical ventilation. VFDs = 28 - x if successfully liberated from ventilation x days after initiation. VFDs = 0 if the subject is mechanically ventilated for \>28 days.
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Ventilator Free Days
|
26 days
Interval 23.0 to 28.0
|
26 days
Interval 22.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: all patients had MI and CVA work up when clinically indicated by attending in charge.
MI and CVA were diagnosed by health care providers and documented in the EMR.
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Incidence of Arterial Thrombotic Complications: Myocardial Infarction (MI) and Cerebrovascular Accident (CVA).
|
0 percentage of patients
|
0 percentage of patients
|
SECONDARY outcome
Timeframe: 30 daysMortality due to any cause was assessed.
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
All-cause Mortality
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysICU-free days will be calculated based on (28 - number of days spent in the ICU) formula
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Intensive Care Unit (ICU) Days
|
24 days
Interval 15.0 to 25.0
|
23 days
Interval 15.0 to 26.0
|
SECONDARY outcome
Timeframe: Up to 28 daysAs measured by Denver MOF score, which grades (from 0-3, with 3 indicating worst dysfunction) four organ systems (lung, kidney, liver, heart), thus varying from 0 to 12 (worst possible dysfunctions) and defines MOF as score \> 3.
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Incidence of Multiple Organ Failure (MOF)
|
0 percentage of patients
|
0 percentage of patients
|
POST_HOC outcome
Timeframe: Within 30 days after injuryIncidence of pulmonary embolism (PE)
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Pulmonary Embolism
|
0 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: 30 daysIncludes the incidence of both deep venous thrombosis (DVT) and pulmonary embolism (PE)
Outcome measures
| Measure |
Experimental
n=19 Participants
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 Participants
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Incidence of Venous Thromboembolism (VTE)
|
0 percentage of patients
|
22.2 percentage of patients
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Control
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=19 participants at risk
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 participants at risk
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • 30 days following the injury
|
5.6%
1/18 • Number of events 1 • 30 days following the injury
|
|
Gastrointestinal disorders
Gastro-intestinal bleeding
|
0.00%
0/19 • 30 days following the injury
|
5.6%
1/18 • Number of events 1 • 30 days following the injury
|
Other adverse events
| Measure |
Experimental
n=19 participants at risk
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Aspirin and Rosuvastatin: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
|
Control
n=18 participants at risk
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Placebo (for Aspirin and Rosuvastatin): Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/19 • 30 days following the injury
|
5.6%
1/18 • Number of events 1 • 30 days following the injury
|
Additional Information
Study Coordinator, James Chandler
Denver Health Medical Center
Phone: 303-602-3798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place