N/A N=40 Randomized Double-blind Treatment

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

Total Hip Replacement

Bottom Line

View on ClinicalTrials.gov: NCT01782859 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Serum Prothrombin Fragment 1 and 2 (PF 1.2) — 334.15; 298.12; 778.33; 619.21 pmol/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Prednisone (Drug); Hydrocortisone (Drug); Placebo (for Prednisone) (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Prothrombin Fragment 1 and 2 (PF 1.2)	334.15; 298.12; 778.33; 619.21; 1306.76; 1138.65	—
PRIMARY Plasmin-a 2 Antiplasmin Complex (PAP)	924.67; 1011.17; 1361.23; 2251.33; 2251.33; 2455.71	—
SECONDARY Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)	2.98; 5.69; 4.46; 4.47; 89.21; 56.72	—
SECONDARY Desmosine Level (Marker of Lung Injury)	—	—
SECONDARY Pain at 3 Months Post-op	0.92; 0.54	—

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.

Eligibility Criteria

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 90 years of age
Patients with history of prior difficulties tolerating corticosteroids

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01782859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.