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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Placebo   Prednisone/Hydrocortisone
STARTED   20   20 
COMPLETED   14   13 
NOT COMPLETED   6   7 
Protocol Violation                6                6 
Withdrawal by Subject                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Placebo   Prednisone/Hydrocortisone   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   13   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.13  (7.16)   66.21  (8.80)   65.66  (7.87) 
Gender 
[Units: Participants]
Count of Participants
     
Female      8  57.1%      9  69.2%      17  63.0% 
Male      6  42.9%      4  30.8%      10  37.0% 
Region of Enrollment 
[Units: Participants]
     
United States   14   13   27 
Body mass index 
[Units: Kg/(m^2)]
Mean (Standard Deviation)
 26.04  (3.92)   28.03  (4.86)   27.00  (4.43) 


  Outcome Measures

1.  Primary:   Serum Prothrombin Fragment 1 and 2 (PF 1.2)   [ Time Frame: First 24 hours after surgery ]

2.  Primary:   Plasmin-a 2 Antiplasmin Complex (PAP)   [ Time Frame: First 24 hours after surgery ]

3.  Secondary:   Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)   [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]

4.  Secondary:   Desmosine Level (Marker of Lung Injury)   [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]

5.  Secondary:   Pain at 3 Months Post-op   [ Time Frame: 3 months postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: juleselyseek@hss.edu



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