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Biological

PRP Injections for Hemophilia

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have failed at least six weeks of conventional conservative treatments (such as medication or physical therapy)

Be older than 18 years old

Must not have

Prior orthobiologic injection into the affected joint

Thrombocytopenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to demonstrate that using a low-cost platelet-rich plasma (PRP) injection can be safe and effective for patients with bleeding disorders affecting their joints. Participants will receive injections for their joint

Who is the study for?

This trial is for individuals with hemophilia who suffer from hemarthropathy, a condition causing joint pain and swelling due to bleeding. Participants must be able to attend 1-2 clinic visits and complete surveys over six months.

What is being tested?

The study tests low-cost platelet-rich plasma (PRP) injections as a treatment for joint issues in hemophilia patients. It aims to prove that PRP can be administered safely without expensive equipment while monitoring outcomes.

What are the potential side effects?

Potential side effects of PRP injections may include pain at the injection site, infection, tissue damage, or increased inflammation in the treated joint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried standard treatments like medication or physical therapy for over six weeks without improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an orthobiologic injection in my affected joint.

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I have a low platelet count.

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I cannot receive factor treatments before PRP injections.

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I currently have an infection at the site where I would receive an injection.

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I cannot walk by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain (numeric pain rating system)

Secondary study objectives

Foot and Ankle Outcome Score (FAOS)

Quick Disabilities of Arm Shoulder and Hand (QuickDASH)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRP InjectionExperimental Treatment1 Intervention

45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: We will perform a full analysis (a complete blood count \[CBC\] with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, we will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples."

0 / 6Eligibility criteria met