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Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT01815918
Recruitment Status : Completed
First Posted : March 21, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:

One postoperative complication following unilateral or bilateral total knee arthroplasty is thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled clinical trial, researchers are investigating the effect of steroids on biochemical markers of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have been linked to postoperative depression following total knee arthroplasty surgery. Hence the investigators are also checking if use of hydrocortisone, a steroid, may help reduce the incidence of postoperative depression.

Other studies have shown that surgery causes some reaction in the body that is consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body. It may also lead to clotting disorders and result in blood clots. In a previous study by this principal investigator (see reference 22, "Use of low-dose steroids in decreasing cytokine release during bilateral total knee arthroplasty"), hydrocortisone was administered over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty. The investigator found lower levels of cellular markers consistent with inflammation (specifically the protein, IL-6). Steroid use also showed additional benefits, such as decreased pain and better range of motion at the knee.

In this study, investigators recruit patients undergoing total knee arthroplasty surgery. Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients' oral analgesic use. To assess patients' well-being, patients are contacted one month and 3 months following their surgeries and administered the Patient Health Questionnaire (see reference 23, "The PHQ-9: validity of a brief depression severity measure.") arthroplasty.


Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Drug: Hydrocortisone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty
Study Start Date : February 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Placebo Comparator: Placebo
Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
Drug: Placebo
Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose.

Active Comparator: Treatment
Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Drug: Hydrocortisone
Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
Other Names:
  • Ala-Cort
  • Ala-Scalp HP
  • Anusol HC
  • Aquanil HC
  • Beta HC
  • Cetacort
  • Colocort
  • Corta-Cap




Primary Outcome Measures :
  1. Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation [ Time Frame: Baseline and up to 4 hours following surgery ]
    Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP

  2. Plasmin-alpha-2-antiplasmin Complex (PAP), a Marker of Fibrinolysis [ Time Frame: Baseline and up to 4 hours following surgery ]
    Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP


Secondary Outcome Measures :
  1. Hydrocortisone's Effect on Depression [ Time Frame: one month and up to 3 months following surgery ]
    Elevated IL-6 has been linked to post-operative depression following total knee replacement surgery. Patients will be administered the patient health questionnaire (PHQ-9) one month and 3 months following surgery to assess their well-being.

  2. Pain Scores and Opioid Consumption [ Time Frame: one month and up to 3 months following surgery ]
    Pain scores (rated on a scale of 0-10) will be taken throughout study participation. We will also record analgesic use to see if patients who received hydrocortisone needed fewer pain killers to control their postoperative pain.

  3. Blinding Assessment [ Time Frame: one month and up to 3 months following surgery ]
    Throughout each patient's study participation, the patient and the data collector will be asked to guess their treatment status. This helps ascertain if there is an association between blinding status, treatment effect and the depression measure.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing unilateral or bilateral total knee replacement
  • Age 50-90

Exclusion Criteria:

  • All patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
  • Patients who are smokers
  • Patients under 50 years of age
  • Patients over 90 years of age
  • Patients with diabetes
  • Patients with a prior history of corticosteroid intolerance
  • Patients with previous complications of steroid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815918


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Kethy Jules-Elysée, M.D. Hospital for Special Surgery, New York

Additional Information:
Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01815918     History of Changes
Other Study ID Numbers: 11007
First Posted: March 21, 2013    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017

Keywords provided by Hospital for Special Surgery, New York:
Orthopedic Procedures
Prostheses and Implants
Joint Prosthesis
Knee Prosthesis
Arthroplasty, Knee
Thromboembolism
Inflammation
B-Cell Differentiation Factor-2
Differentiation Factor-2, B-Cell
B-Cell Stimulatory Factor-2
BSF-2
IFN-beta 2
MGI-2
Interleukin-6 (IL-6)
Steroids
Pregnenediones
Hydrocortisone
Physiological Effects of Drugs
Therapeutic Uses

Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents