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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

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE February 4, 2013
Results First Submitted Date  ICMJE April 4, 2016
Results First Posted Date  ICMJE May 10, 2016
Last Update Posted Date January 5, 2017
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Serum Prothrombin Fragment 1 and 2 (PF 1.2) [ Time Frame: First 24 hours after surgery ]
  • Plasmin-a 2 Antiplasmin Complex (PAP) [ Time Frame: First 24 hours after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • Serum Prothrombin Fragment 1 and 2 (PF 1.2) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery
  • Plasmin-a 2 Antiplasmin Complex (PAP) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery
Change History Complete list of historical versions of study NCT01782859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
  • 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 ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
  • 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 ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
  • Pain at 3 Months Post-op [ Time Frame: 3 months postoperatively ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • 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 ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery
  • 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 ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
Official Title  ICMJE Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
Brief Summary Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Total Hip Replacement
Intervention  ICMJE
  • Drug: Prednisone
    Other Names:
    • Low dose steroids to be administered preoperatively and then repeated over a 24-hour period
    • 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. Another dose of 100 mg hydrocortisone IV 8 hours after
  • Drug: Hydrocortisone
    Other Names:
    • Low dose steroids to be administered preoperatively and then repeated over a 24-hour period
    • 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. Another dose of 100 mg hydrocortisone IV 8 hours after
  • Drug: Placebo (for Prednisone)
    Other Name: Lactose filler to mimic 20 mg prednisone tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Control group
    Intervention: Drug: Placebo (for Prednisone)
  • Active Comparator: 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
    Interventions:
    • Drug: Prednisone
    • Drug: Hydrocortisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
  • Patients between the age of 50 and 90

Exclusion Criteria:

  • Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
  • Patients who are smokers
  • Patients who have diabetes
  • Patients who are <50 and >90 years of age
  • Patients with history of prior difficulties tolerating corticosteroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01782859
Other Study ID Numbers  ICMJE 2012-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital for Special Surgery, New York
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP