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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02332616
Other study ID # HK_VL_08_2014b
Secondary ID
Status Completed
Phase Phase 3
First received January 5, 2015
Last updated April 7, 2016
Start date January 2015
Est. completion date April 2016

Study information

Verified date April 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial Summary

This study evaluates the pathophysiological effects of a single dose of methylprednisolone administered prior to total knee-arthroplasty surgery. The investigators examine the effect on complement activation.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving methylprednisolone will experience beneficial inhibition of the undesirable parts of the complement activation.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Drug:
Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen NV

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma and serum Pentraxin-3 concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
Secondary Change in plasma and serum Complement Component 3 concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
Secondary Change in plasma and serum Complement Component 4 concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
Secondary Change in plasma and serum Mannose-binding lectin concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
Secondary Change in plasma and serum Ficolin-1, -2 and -3 concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
Secondary Change in plasma and serum Terminal Complement Complex concentrations from baseline (before surgery) to 48 hours after surgery baseline to 48 hours No
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