- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782859
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
November 7, 2016 updated by: Hospital for Special Surgery, New York
Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Control group
|
Other Names:
|
Active Comparator: Prednisone/hydrocortisone
Steroid group will receive the following:
|
Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Time Frame: First 24 hours after surgery
|
First 24 hours after surgery
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Plasmin-a 2 Antiplasmin Complex (PAP)
Time Frame: First 24 hours after surgery
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First 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
|
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.
|
Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
|
Pain at 3 Months Post-op
Time Frame: 3 months postoperatively
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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.
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3 months postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 31, 2013
First Posted (Estimate)
February 4, 2013
Study Record Updates
Last Update Posted (Estimate)
January 5, 2017
Last Update Submitted That Met QC Criteria
November 7, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- 2012-008 (Other Identifier: Kantonale Ethikkommission AG/ SO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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