Trial Outcomes & Findings for Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock (NCT NCT02071290)
NCT ID: NCT02071290
Last Updated: 2023-06-07
Results Overview
Change in neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
0 (Admission), 1, 3, and 24 hours after intervention
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
Sham Remote Ischemic Conditioning
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Sham Remote Ischemic Conditioning
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 17 • n=21 Participants
|
40 years
STANDARD_DEVIATION 17 • n=18 Participants
|
39 years
STANDARD_DEVIATION 17 • n=39 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=21 Participants
|
4 Participants
n=18 Participants
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=21 Participants
|
14 Participants
n=18 Participants
|
30 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
21 Participants
n=21 Participants
|
18 Participants
n=18 Participants
|
39 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Neutrophil Oxidative Burst Activity
Admission
|
302 Median Fluorescence Intensity
Interval 222.0 to 383.0
|
302 Median Fluorescence Intensity
Interval 223.0 to 652.0
|
|
Neutrophil Oxidative Burst Activity
1 Hour
|
298 Median Fluorescence Intensity
Interval 235.0 to 366.0
|
268 Median Fluorescence Intensity
Interval 194.0 to 536.0
|
|
Neutrophil Oxidative Burst Activity
3 Hour
|
229 Median Fluorescence Intensity
Interval 166.0 to 311.0
|
202 Median Fluorescence Intensity
Interval 144.0 to 384.0
|
|
Neutrophil Oxidative Burst Activity
24 Hour
|
337 Median Fluorescence Intensity
Interval 257.0 to 559.0
|
461 Median Fluorescence Intensity
Interval 256.0 to 580.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in PMA stimulated neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours. Measured by flow cytometry using whole blood samples.
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Neutrophil Oxidative Burst Activity (PMA Stimulated)
Admission
|
28812 Median Fluorescence Intensity
Interval 18030.0 to 52662.0
|
14772 Median Fluorescence Intensity
Interval 10827.0 to 35370.0
|
|
Neutrophil Oxidative Burst Activity (PMA Stimulated)
1 Hour
|
27041 Median Fluorescence Intensity
Interval 15717.0 to 44051.0
|
13044 Median Fluorescence Intensity
Interval 5789.0 to 32778.0
|
|
Neutrophil Oxidative Burst Activity (PMA Stimulated)
3 Hour
|
19027 Median Fluorescence Intensity
Interval 7871.0 to 37239.0
|
8753 Median Fluorescence Intensity
Interval 4579.0 to 24316.0
|
|
Neutrophil Oxidative Burst Activity (PMA Stimulated)
24 Hour
|
4680 Median Fluorescence Intensity
Interval 2394.0 to 13554.0
|
2667 Median Fluorescence Intensity
Interval 1483.0 to 5595.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hours after interventionChange in neutrophil adhesion molecule (CD11b) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Neutrophil Adhesion Molecule Expression (CD11b)
Admission
|
5492 Median Fluorescence Intensity
Interval 3533.0 to 8415.0
|
4341 Median Fluorescence Intensity
Interval 2552.0 to 7786.0
|
|
Neutrophil Adhesion Molecule Expression (CD11b)
1 Hour
|
5108 Median Fluorescence Intensity
Interval 3453.0 to 7993.0
|
5808 Median Fluorescence Intensity
Interval 3345.0 to 10511.0
|
|
Neutrophil Adhesion Molecule Expression (CD11b)
3 Hour
|
5889 Median Fluorescence Intensity
Interval 3253.0 to 8720.0
|
6362 Median Fluorescence Intensity
Interval 4136.0 to 7197.0
|
|
Neutrophil Adhesion Molecule Expression (CD11b)
24 Hour
|
9998 Median Fluorescence Intensity
Interval 6385.0 to 12919.0
|
6013 Median Fluorescence Intensity
Interval 3464.0 to 9852.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in neutrophil adhesion molecule (CD62L) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Neutrophil Adhesion Molecule Expression (CD62L)
Admission
|
5913 Median Fluorescence Intensity
Interval 4959.0 to 6879.0
|
5556 Median Fluorescence Intensity
Interval 4084.0 to 6807.0
|
|
Neutrophil Adhesion Molecule Expression (CD62L)
1 Hour
|
5404 Median Fluorescence Intensity
Interval 4352.0 to 6502.0
|
5452 Median Fluorescence Intensity
Interval 4743.0 to 7090.0
|
|
Neutrophil Adhesion Molecule Expression (CD62L)
3 Hour
|
4414 Median Fluorescence Intensity
Interval 3965.0 to 5770.0
|
4995 Median Fluorescence Intensity
Interval 4196.0 to 5603.0
|
|
Neutrophil Adhesion Molecule Expression (CD62L)
24 Hour
|
3742 Median Fluorescence Intensity
Interval 3228.0 to 4704.0
|
3569 Median Fluorescence Intensity
Interval 2629.0 to 4891.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Endothelial Injury (Heparan Sulfate)
Admission
|
6.7 ng/mL
Interval 3.4 to 8.4
|
6.0 ng/mL
Interval 3.3 to 9.5
|
|
Endothelial Injury (Heparan Sulfate)
1 Hour
|
3.3 ng/mL
Interval 2.2 to 7.2
|
4.9 ng/mL
Interval 2.5 to 10.2
|
|
Endothelial Injury (Heparan Sulfate)
3 Hour
|
3.3 ng/mL
Interval 1.9 to 7.1
|
3.6 ng/mL
Interval 3.1 to 8.3
|
|
Endothelial Injury (Heparan Sulfate)
24 Hour
|
3.0 ng/mL
Interval 1.9 to 5.8
|
3.7 ng/mL
Interval 2.9 to 6.5
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=20 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=16 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Endothelial Injury (Hyaluronan)
Admission
|
45.9 ng/mL
Interval 24.4 to 78.1
|
36.6 ng/mL
Interval 18.9 to 79.1
|
|
Endothelial Injury (Hyaluronan)
1 Hour
|
35.6 ng/mL
Interval 21.3 to 65.1
|
43.1 ng/mL
Interval 17.6 to 65.3
|
|
Endothelial Injury (Hyaluronan)
3 Hour
|
19.2 ng/mL
Interval 13.9 to 52.6
|
26.5 ng/mL
Interval 13.3 to 43.2
|
|
Endothelial Injury (Hyaluronan)
24 Hour
|
54.9 ng/mL
Interval 38.1 to 103.3
|
67.1 ng/mL
Interval 34.2 to 130.9
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Endothelial Injury (Syndecan-1)
Admission
|
25.3 ng/mL
Interval 16.6 to 67.8
|
27.2 ng/mL
Interval 13.7 to 79.3
|
|
Endothelial Injury (Syndecan-1)
1 Hour
|
35.0 ng/mL
Interval 18.5 to 57.9
|
31.6 ng/mL
Interval 16.3 to 109.7
|
|
Endothelial Injury (Syndecan-1)
3 Hour
|
39.4 ng/mL
Interval 15.3 to 64.4
|
48 ng/mL
Interval 24.4 to 86.4
|
|
Endothelial Injury (Syndecan-1)
24 Hour
|
24.3 ng/mL
Interval 17.9 to 55.6
|
38.3 ng/mL
Interval 23.4 to 67.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, and 24 hours after interventionChange in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma TNF-α
Admission
|
2.15 pg/mL
Interval 1.39 to 3.05
|
2.67 pg/mL
Interval 1.65 to 3.25
|
|
Plasma TNF-α
1 Hour
|
1.97 pg/mL
Interval 1.51 to 2.68
|
2.34 pg/mL
Interval 1.89 to 3.43
|
|
Plasma TNF-α
3 Hour
|
1.95 pg/mL
Interval 1.71 to 3.37
|
2.15 pg/mL
Interval 1.72 to 3.06
|
|
Plasma TNF-α
24 Hour
|
2.59 pg/mL
Interval 2.07 to 3.52
|
2.72 pg/mL
Interval 2.11 to 3.6
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma IL-6
1 Hour
|
11.95 pg/mL
Interval 6.99 to 98.23
|
21.62 pg/mL
Interval 5.33 to 51.99
|
|
Plasma IL-6
3 Hour
|
18.77 pg/mL
Interval 11.82 to 90.98
|
23.30 pg/mL
Interval 8.92 to 109.82
|
|
Plasma IL-6
Admission
|
7.73 pg/mL
Interval 3.77 to 60.09
|
8.04 pg/mL
Interval 4.04 to 30.89
|
|
Plasma IL-6
24 Hour
|
65.72 pg/mL
Interval 13.74 to 133.73
|
51.56 pg/mL
Interval 25.63 to 137.76
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma IL-8
Admission
|
7.1 pg/mL
Interval 3.11 to 11.5
|
4.56 pg/mL
Interval 2.78 to 7.46
|
|
Plasma IL-8
1 Hour
|
6.63 pg/mL
Interval 2.95 to 36.42
|
5.81 pg/mL
Interval 3.01 to 14.83
|
|
Plasma IL-8
3 Hour
|
9.85 pg/mL
Interval 4.2 to 53.45
|
7.98 pg/mL
Interval 2.82 to 34.05
|
|
Plasma IL-8
24 Hour
|
15.12 pg/mL
Interval 5.5 to 26.65
|
9.53 pg/mL
Interval 4.97 to 35.91
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma IL-10
Admission
|
1.93 pg/mL
Interval 0.89 to 17.8
|
3.61 pg/mL
Interval 1.1 to 8.03
|
|
Plasma IL-10
1 Hour
|
5.88 pg/mL
Interval 2.22 to 43.42
|
8.58 pg/mL
Interval 1.85 to 21.7
|
|
Plasma IL-10
3 Hour
|
5.56 pg/mL
Interval 1.33 to 11.27
|
6.20 pg/mL
Interval 1.24 to 17.06
|
|
Plasma IL-10
24 Hour
|
3.15 pg/mL
Interval 0.84 to 6.86
|
2.11 pg/mL
Interval 0.9 to 11.47
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in ROTEM parameter Clotting Time (CT) over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ROTEM EXTEM CT
Admission
|
71 Seconds
Interval 61.0 to 89.0
|
65 Seconds
Interval 60.0 to 69.0
|
|
ROTEM EXTEM CT
1 Hour
|
64 Seconds
Interval 59.0 to 73.0
|
62 Seconds
Interval 58.0 to 69.0
|
|
ROTEM EXTEM CT
3 Hour
|
68 Seconds
Interval 60.0 to 85.0
|
59 Seconds
Interval 56.0 to 71.0
|
|
ROTEM EXTEM CT
24 Hour
|
66 Seconds
Interval 55.0 to 72.0
|
71 Seconds
Interval 64.0 to 73.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ROTEM EXTEM CFT
Admission
|
90 Seconds
Interval 74.0 to 136.0
|
73 Seconds
Interval 55.0 to 85.0
|
|
ROTEM EXTEM CFT
1 Hour
|
96 Seconds
Interval 79.0 to 135.0
|
108 Seconds
Interval 73.0 to 127.0
|
|
ROTEM EXTEM CFT
3 Hour
|
125 Seconds
Interval 91.0 to 148.0
|
103 Seconds
Interval 82.0 to 129.0
|
|
ROTEM EXTEM CFT
24 Hour
|
102 Seconds
Interval 76.0 to 115.0
|
91 Seconds
Interval 84.0 to 130.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in ROTEM parameter A10 over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ROTEM EXTEM A10
Admission
|
54 mm
Interval 44.0 to 59.0
|
56 mm
Interval 53.0 to 64.0
|
|
ROTEM EXTEM A10
1 Hour
|
52 mm
Interval 44.0 to 56.0
|
48 mm
Interval 43.0 to 56.0
|
|
ROTEM EXTEM A10
3 Hour
|
46 mm
Interval 42.0 to 54.0
|
51 mm
Interval 43.0 to 54.0
|
|
ROTEM EXTEM A10
24 Hour
|
52 mm
Interval 48.0 to 59.0
|
54 mm
Interval 47.0 to 56.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in ROTEM parameter Alpha Angle over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ROTEM EXTEM Alpha Angle
Admission
|
72 Degrees
Interval 65.0 to 75.0
|
75 Degrees
Interval 73.0 to 79.0
|
|
ROTEM EXTEM Alpha Angle
1 Hour
|
71 Degrees
Interval 64.0 to 74.0
|
71 Degrees
Interval 65.0 to 76.0
|
|
ROTEM EXTEM Alpha Angle
3 Hour
|
68 Degrees
Interval 63.0 to 74.0
|
69 Degrees
Interval 65.0 to 74.0
|
|
ROTEM EXTEM Alpha Angle
24 Hour
|
73 Degrees
Interval 70.0 to 76.0
|
72 Degrees
Interval 68.0 to 76.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in ROTEM parameter maximum lysis (ML) over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ROTEM EXTEM ML
Admission
|
6 Percent
Interval 3.0 to 11.0
|
6 Percent
Interval 5.0 to 12.0
|
|
ROTEM EXTEM ML
1 Hour
|
5 Percent
Interval 1.0 to 6.0
|
4 Percent
Interval 3.0 to 7.0
|
|
ROTEM EXTEM ML
3 Hour
|
4 Percent
Interval 1.0 to 6.0
|
4 Percent
Interval 3.0 to 7.0
|
|
ROTEM EXTEM ML
24 Hour
|
8 Percent
Interval 6.0 to 12.0
|
7 Percent
Interval 4.0 to 11.0
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma D-Dimer levels over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=20 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma D-Dimer
Admission
|
0.96 ug/mL
Interval 0.26 to 7.78
|
1.56 ug/mL
Interval 0.57 to 10.12
|
|
Plasma D-Dimer
1 Hour
|
0.59 ug/mL
Interval 0.3 to 3.63
|
1.50 ug/mL
Interval 0.71 to 10.04
|
|
Plasma D-Dimer
3 Hour
|
0.85 ug/mL
Interval 0.37 to 3.14
|
1.53 ug/mL
Interval 0.66 to 10.91
|
|
Plasma D-Dimer
24 Hour
|
1.64 ug/mL
Interval 0.52 to 4.27
|
1.70 ug/mL
Interval 0.6 to 3.83
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma Protein C levels over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=20 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma Protein C
Admission
|
0.65 U/mL
Interval 0.5 to 0.82
|
0.71 U/mL
Interval 0.66 to 0.81
|
|
Plasma Protein C
1 Hour
|
0.62 U/mL
Interval 0.5 to 0.95
|
0.70 U/mL
Interval 0.58 to 0.81
|
|
Plasma Protein C
3 Hour
|
0.70 U/mL
Interval 0.54 to 0.92
|
0.74 U/mL
Interval 0.69 to 0.88
|
|
Plasma Protein C
24 Hour
|
0.82 U/mL
Interval 0.71 to 1.0
|
0.75 U/mL
Interval 0.66 to 0.98
|
PRIMARY outcome
Timeframe: 0 (Admission), 1, 3, 24 hoursChange in plasma fibrinogen levels over 24 hours from Admission
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=20 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Plasma Fibrinogen
Admission
|
1.65 g/mL
Interval 1.29 to 2.54
|
2.44 g/mL
Interval 1.81 to 2.81
|
|
Plasma Fibrinogen
1 Hour
|
2.09 g/mL
Interval 1.34 to 2.64
|
2.41 g/mL
Interval 1.54 to 2.7
|
|
Plasma Fibrinogen
3 Hour
|
2.11 g/mL
Interval 1.65 to 2.68
|
2.35 g/mL
Interval 1.88 to 2.7
|
|
Plasma Fibrinogen
24 Hour
|
3.91 g/mL
Interval 2.93 to 4.26
|
3.55 g/mL
Interval 3.04 to 4.26
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Ventilator Free Days
|
27 Days
Interval 24.0 to 28.0
|
26 Days
Interval 24.0 to 28.0
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
ICU Free Days
|
27 Days
Interval 23.0 to 28.0
|
25 Days
Interval 18.0 to 27.0
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Hospital Free Days
|
24 Days
Interval 11.0 to 26.0
|
16 Days
Interval 7.0 to 22.0
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Nosocomial Infections
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
24 Hour Mortality
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 28 days or dischargeSecondary clinical outcomes
Outcome measures
| Measure |
Sham Remote Ischemic Conditioning
n=21 Participants
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 Participants
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
28 Day Mortality
|
1 Participants
|
1 Participants
|
Adverse Events
Sham Remote Ischemic Conditioning
Serious events: 6 serious events
Other events: 0 other events
Deaths: 1 deaths
Remote Ischemic Conditioning
Serious events: 9 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sham Remote Ischemic Conditioning
n=21 participants at risk
Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
Remote Ischemic Conditioning
n=18 participants at risk
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital
|
|---|---|---|
|
Infections and infestations
Nosocomial infection
|
23.8%
5/21 • Number of events 5 • up to 28 days or discharge
Chart review by research staff
|
33.3%
6/18 • Number of events 6 • up to 28 days or discharge
Chart review by research staff
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
19.0%
4/21 • Number of events 4 • up to 28 days or discharge
Chart review by research staff
|
22.2%
4/18 • Number of events 4 • up to 28 days or discharge
Chart review by research staff
|
|
Vascular disorders
Thromboembolism
|
9.5%
2/21 • Number of events 2 • up to 28 days or discharge
Chart review by research staff
|
11.1%
2/18 • Number of events 2 • up to 28 days or discharge
Chart review by research staff
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place