N/A
Completed N=40
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery
Total Hip Replacement
Source: ClinicalTrials.gov NCT01782859 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Serum Prothrombin Fragment 1 and 2 (PF 1.2) — 334.15; 298.12; 778.33; 619.21 pmol/mL
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.
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 | — |
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
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. Informational only — not medical advice.