Trial Outcomes & Findings for Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery (NCT NCT01782859)
NCT ID: NCT01782859
Last Updated: 2017-01-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
First 24 hours after surgery
Results posted on
2017-01-05
Participant Flow
Participant milestones
| Measure |
Placebo
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
n=13 Participants
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.13 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
66.21 years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
65.66 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
|
Gender
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Body mass index
|
26.04 kg/(m^2)
STANDARD_DEVIATION 3.92 • n=5 Participants
|
28.03 kg/(m^2)
STANDARD_DEVIATION 4.86 • n=7 Participants
|
27.00 kg/(m^2)
STANDARD_DEVIATION 4.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: First 24 hours after surgeryOutcome measures
| Measure |
Placebo
n=14 Participants
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
n=13 Participants
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
4 hours postoperatively
|
1306.76 pmol/mL
Standard Deviation 445.4
|
1138.65 pmol/mL
Standard Deviation 435.7
|
|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
6 hours postoperatively
|
1175.71 pmol/mL
Standard Deviation 400.9
|
1032.52 pmol/mL
Standard Deviation 466.8
|
|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
24 hours postoperatively
|
356.79 pmol/mL
Standard Deviation 94.9
|
422.61 pmol/mL
Standard Deviation 191.6
|
|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Baseline
|
334.15 pmol/mL
Standard Deviation 193.9
|
298.12 pmol/mL
Standard Deviation 124.6
|
|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Wound Closure
|
778.33 pmol/mL
Standard Deviation 353.7
|
619.21 pmol/mL
Standard Deviation 154.9
|
PRIMARY outcome
Timeframe: First 24 hours after surgeryOutcome measures
| Measure |
Placebo
n=14 Participants
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
n=13 Participants
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Plasmin-a 2 Antiplasmin Complex (PAP)
Baseline
|
924.67 mcg/L
Standard Deviation 324.7
|
1011.17 mcg/L
Standard Deviation 212.3
|
|
Plasmin-a 2 Antiplasmin Complex (PAP)
Wound Closure
|
1361.23 mcg/L
Standard Deviation 527.7
|
2251.33 mcg/L
Standard Deviation 680.1
|
|
Plasmin-a 2 Antiplasmin Complex (PAP)
4 hours postoperatively
|
2251.33 mcg/L
Standard Deviation 680.1
|
2455.71 mcg/L
Standard Deviation 458.0
|
|
Plasmin-a 2 Antiplasmin Complex (PAP)
6 hours postoperatively
|
2283.18 mcg/L
Standard Deviation 711.0
|
2379.57 mcg/L
Standard Deviation 395.3
|
|
Plasmin-a 2 Antiplasmin Complex (PAP)
24 hours postoperatively
|
996.39 mcg/L
Standard Deviation 251.1
|
914.16 mcg/L
Standard Deviation 186.6
|
SECONDARY outcome
Timeframe: Participants will be followed from the time of surgery until discharge, expected average of 3-5 daysThe time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Outcome measures
| Measure |
Placebo
n=14 Participants
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
n=13 Participants
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
Baseline
|
2.98 picograms/milliliter
Standard Deviation 2.3
|
5.69 picograms/milliliter
Standard Deviation 8.7
|
|
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
Wound closure
|
4.46 picograms/milliliter
Standard Deviation 4.2
|
4.47 picograms/milliliter
Standard Deviation 6.3
|
|
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
4 hours postoperatively
|
89.21 picograms/milliliter
Standard Deviation 52.1
|
56.72 picograms/milliliter
Standard Deviation 27.6
|
|
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
6 hours postoperatively
|
115.17 picograms/milliliter
Standard Deviation 56.1
|
64.4 picograms/milliliter
Standard Deviation 33.7
|
|
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
24 hours postoperatively
|
176.79 picograms/milliliter
Standard Deviation 91.4
|
68.51 picograms/milliliter
Standard Deviation 45.8
|
SECONDARY outcome
Timeframe: Participants will be followed from the time of surgery until discharge, expected average of 3-5 daysPopulation: Desmosine levels were not analyzed.
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months postoperativelyAt 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.
Outcome measures
| Measure |
Placebo
n=14 Participants
Control group
Placebo (for Prednisone)
|
Prednisone/Hydrocortisone
n=13 Participants
Steroid group will receive the following:
1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
|
|---|---|---|
|
Pain at 3 Months Post-op
|
0.92 units on a scale
Standard Deviation 0.76
|
0.54 units on a scale
Standard Deviation 0.66
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prednisone/Hydrocortisone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place