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

Total Hip Replacement Clinical Trial

Official title:

Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782859
• Other study ID #: 2012-008
• Status: Recruiting
• Phase: N/A
• First received: January 28, 2013
• Last updated: January 31, 2013
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Hospital for Special Surgery, New York
• Contact: Kethy Jules-Elysee, MD
• Phone: 212-606-1206
• Email: JulesElyseeK[@]hss.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Drug:
• Prednisone

• Hydrocortisone

• Placebo (for Prednisone)

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum prothrombin fragment 1 and 2 (PF 1.2)	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	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	No
Primary	Plasmin-a 2 antiplasmin complex (PAP)	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	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	No
Secondary	IL-6 cytokine release (inflammatory marker)	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	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	No
Secondary	Desmosine level (marker of lung injury)	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	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	No