Trial intelligence / Profile preview

PROCRIT vs PAD in Total Joint Arthroplasty

NCT00401869Phase 4

Key facts

Status: Completed
Start: Feb 1999
Sponsor: Ortho Biotech Inc.
Modality: Biologic, rProtein (Recombinant Protein)

Drugs: epoetin alfa
Conditions: anemia

Overview

Phase 4, randomised, open-label trial of epoetin alfa in anemia (2 arms), sponsored by Ortho Biotech Inc. Primary endpoint: Change in VIGOR score. Started Feb 1999; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

PROCRIT
Epoetin alfa 600 IU/kg SC weekly x3 pre-op + 1 dose post-op
PAD
Preoperative Autologous Blood Donation

Who it enrols

Patients scheduled for elective unilateral primary total joint arthroplasty of hip or knee with pretreatment hemoglobin of 11-14 g/dL. Excludes patients with uncontrolled hypertension, seizure disorder, history of DVT, or significant other systemic diseases.

Endpoints

Primary

Change in VIGOR scorePost-op Day 14-21

Secondary

Handgrip strengthPost-op Day 14-21
Hemoglobin levelsPost-op Day 14-21
Incidence of transfusionPerioperative period

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