Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia — Hematoboost

Total Knee Arthroplasty Clinical Trial

Official title:
Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia: a Multicenter Randomized Controlled Study

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

This study is a randomized, placebo-controlled, multicenter research design to investigate the effectiveness and safety of a single-dose intravenous iron combined with HuEPO hematopoietic mobilization before surgery in patients undergoing unilateral total knee arthroplasty for the first time. The study consists of a pilot trial and a formal trial. The pilot trial plans to enroll 20 subjects, with 10 subjects randomly assigned to the experimental group and 10 subjects to the control group. After the successful completion of the pilot trial, its safety and effectiveness, as determined by the investigators, hematologists, orthopedic surgeons, and statisticians, and the formal trial will be initiated. The relevant information and results will also be submitted to the ethics review committee. The formal trial plans to enroll 399 eligible subjects, with a random allocation ratio of 2:1 to the experimental group or the control group. To ensure the safety of the subjects, the last subject in the pilot trial will be followed up for 21 days after surgery. The safety and effectiveness of the pilot trial results will be discussed by the investigators, hematologists, orthopedic surgeons, and statisticians before initiating the formal trial. The timing of medication, sample size, and visit points in the formal trial may be adjusted appropriately based on the results of the pilot trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05911438
Study type	Interventional
Source	West China Hospital
Contact	Zeyu Huang, MD, PhD
Phone	18980602287
Email	492385233@qq.com
Status	Not yet recruiting
Phase	N/A
Start date	July 2023
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01616836` - Optimizing Pain and Rehabilitation After Knee Arthroplasty	Phase 3
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT00985920` - Topical Tranexamic Acid for Total Knee Arthroplasty	Phase 4
Completed	`NCT00761956` - A Study to Compare the NexGen CR and CR-Flex Knee Implants	N/A
Completed	`NCT03289247` - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty	N/A
Terminated	`NCT03316118` - US Guided GNB vs Saline Injection for TKA	Phase 4
Recruiting	`NCT05962970` - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty	N/A
Completed	`NCT03317834` - Navio With Total Knee Arthroplasty
Enrolling by invitation	`NCT06188091` - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.