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Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery

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ClinicalTrials.gov Identifier: NCT01782859
Recruitment Status : Completed
First Posted : February 4, 2013
Results First Posted : May 10, 2016
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Total Hip Replacement
Interventions Drug: Prednisone
Drug: Hydrocortisone
Drug: Placebo (for Prednisone)
Enrollment 40

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description

Control group

Placebo (for Prednisone)

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
Period Title: Overall Study
Started 20 20
Completed 14 13
Not Completed 6 7
Reason Not Completed
Protocol Violation             6             6
Withdrawal by Subject             0             1
Arm/Group Title Placebo Prednisone/Hydrocortisone Total
Hide Arm/Group Description

Control group

Placebo (for Prednisone)

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 of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
65.13  (7.16) 66.21  (8.80) 65.66  (7.87)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
8
  57.1%
9
  69.2%
17
  63.0%
Male
6
  42.9%
4
  30.8%
10
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14 13 27
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/(m^2)
Number Analyzed 14 participants 13 participants 27 participants
26.04  (3.92) 28.03  (4.86) 27.00  (4.43)
1.Primary Outcome
Title Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Hide Description [Not Specified]
Time Frame First 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description:

Control group

Placebo (for Prednisone)

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 Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: pmol/mL
Baseline 334.15  (193.9) 298.12  (124.6)
Wound Closure 778.33  (353.7) 619.21  (154.9)
4 hours postoperatively 1306.76  (445.4) 1138.65  (435.7)
6 hours postoperatively 1175.71  (400.9) 1032.52  (466.8)
24 hours postoperatively 356.79  (94.9) 422.61  (191.6)
2.Primary Outcome
Title Plasmin-a 2 Antiplasmin Complex (PAP)
Hide Description [Not Specified]
Time Frame First 24 hours after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description:

Control group

Placebo (for Prednisone)

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 Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: mcg/L
Baseline 924.67  (324.7) 1011.17  (212.3)
Wound Closure 1361.23  (527.7) 2251.33  (680.1)
4 hours postoperatively 2251.33  (680.1) 2455.71  (458.0)
6 hours postoperatively 2283.18  (711.0) 2379.57  (395.3)
24 hours postoperatively 996.39  (251.1) 914.16  (186.6)
3.Secondary Outcome
Title Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
Hide Description The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Time Frame Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description:

Control group

Placebo (for Prednisone)

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 Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter
Baseline 2.98  (2.3) 5.69  (8.7)
Wound closure 4.46  (4.2) 4.47  (6.3)
4 hours postoperatively 89.21  (52.1) 56.72  (27.6)
6 hours postoperatively 115.17  (56.1) 64.4  (33.7)
24 hours postoperatively 176.79  (91.4) 68.51  (45.8)
4.Secondary Outcome
Title Desmosine Level (Marker of Lung Injury)
Hide Description The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Time Frame Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Desmosine levels were not analyzed.
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description:

Control group

Placebo (for Prednisone)

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pain at 3 Months Post-op
Hide Description At 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.
Time Frame 3 months postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description:

Control group

Placebo (for Prednisone)

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

Prednisone

Hydrocortisone

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.92  (0.76) 0.54  (0.66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Prednisone/Hydrocortisone
Hide Arm/Group Description

Control group

Placebo (for Prednisone)

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
All-Cause Mortality
Placebo Prednisone/Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Prednisone/Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Prednisone/Hydrocortisone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kethy Jules-Elysee, MD
Organization: Hospital for Special Surgery
Phone: 2126061206
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01782859     History of Changes
Other Study ID Numbers: 2012-008
First Submitted: January 28, 2013
First Posted: February 4, 2013
Results First Submitted: April 4, 2016
Results First Posted: May 10, 2016
Last Update Posted: January 5, 2017