PROCRIT and Short-Term Outcomes in Orthopedic Surgery
|ClinicalTrials.gov Identifier: NCT00236405|
Recruitment Status : Terminated (The study was terminated due to poor enrollment.)
First Posted : October 12, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia Surgery, Arthroscopy||Drug: epoetin alfa||Phase 2|
The primary objective of this study is to compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on post-operative rehabilitation outcomes in subjects undergoing primary unilateral knee arthroplasty.
Secondary objectives are : 1) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on hemoglobin, change in hemoglobin, number of units transfused and transfusion rate during the study period; and 2) To compare the effect of perioperative administration of PROCRIT to that of preoperative autologous donation on inpatient rehabilitation length of stay.
The study will test the hypothesis that perioperative administration of PROCRIT will improve post-operative rehabilitation outcomes, compared with preoperative autologous donation. 40,000U PROCRIT or Placebo SC in relation to surgery date: Days -21, -14, -7, 0 (day of surgery), 7, and 14.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of of PROCRIT� (Epoetin Alfa) on Short-Term Outcomes in Orthopedic Subjects Undergoing Primary Unilateral Knee Arthroplasty|
|Study Start Date :||March 2005|
|Actual Study Completion Date :||October 2005|
- The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".
- LOS in the inpatient rehabilitation facility; Total FIM score; FIM Physical Sub-score LASA score; FACIT-An score. Safety evaluations include the incidence of adverse events throughout the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236405
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|