Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543368
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Low-Cost Platelet-Rich Plasma for Hemarthropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low-Cost Platelet-Rich Plasma Injection for the Management of Hemarthropathy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Orthopedic complications can be injuries or diseases that affect the bones muscles and joints Hemarthropathy is due to bleeding disorders most commonly hemophilia and can result in severe issues related to chronic amounts of blood in the bodys joints This causes swelling pain and loss of joint function A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs Platelet-rich plasma PRP injection is a method that can reduce the cost of care while still offering a similar standard of care for patients
This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders without the need for expensive equipment while monitoring patient treatment results Study participants will receive injections for joint conditions Being in the study requires attending 1 to 2 in-person visits at the study clinic Participants will also complete surveys using email text messages in person andor on the phone Participation lasts about 6 months
This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders without the need for expensive equipment while monitoring patient treatment results Study participants will receive injections for joint conditions Being in the study requires attending 1 to 2 in-person visits at the study clinic Participants will also complete surveys using email text messages in person andor on the phone Participation lasts about 6 months
Detailed Description:
This study will be performed as a prospective single arm study Consecutive patients eligible for a standard-of-care injection will be enrolled from the Utah Center for Bleeding and Clotting Disorders The University of Utah non-operative sports medicine team currently performs hundreds of injections monthly and the PI works closely with the orthopedic complaints of patients with bleeding disorders From a research standpoint the investigators have successfully performed numerous randomized controlled prospective trials on a variety of musculoskeletal conditions in the past and have already validated this method on a large cohort of patients with knee osteoarthritis OA
Potential subjects will then be approached by a member of the research team to discuss the consideration of taking part in the study if they meet the inclusion criteria of this study project Using all forms of good clinical practice a member of the study team will review with the participant the Informed Consent Form allow participant to read the informed consent ICF and ask questions prior to signing the ICF Potential subjects may also be asked by other physicians or staff members familiar with the study
Low Cost-Platelet Rich Plasma LC-PRP preparation method See Documents for full details This method follows the same procedures as the standard-of-care FDA-cleared method used by numerous commercial machines thus it does not require additional FDA clearance or approval To summarize the full method in the appendix 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 The investigators will perform a full analysis a complete blood count CBC with differential on subjects whole blood and their prepared LC-PRP Importantly the investigators will include all data required in the PRP minimum reporting standards including platelet differential leukocyte and red cell analysis of all samples Also note that although the investigators are collecting these values for the purposes of the study CBC values are not needed in the community
Injections A total of 20 joints estimated 10-15 patients will receive injections performed at day 0 and 3 weeks for a total of two injections - two injections have demonstrated superior outcomes to one and will increase our number of injections to improve the proof of feasibility All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1 lidocaine to the extra-articular structures namely the skin and joint capsule to increase comfort Note though the investigators are using ultrasound guidance to ensure that they are guaranteeing accurate injectate placement for this study this is not necessarily required in the community setting These will be performed after the patients typical factor infusions if applicable
Questionnaire The investigators will collect demographic information along with baseline and subsequent functional patient reported outcomes namely the WOMAC knee FAOS ankle and the QuickDASH elbow REDCap will be used to administer surveys and store data The investigators will additionally ask about adverse events pain global satisfaction global injection satisfaction and medications
Data collection time points and follow-up Follow-up data see timeline below will be administered electronically Subjects will be queried by email text message in person andor by telephone regarding treatment outcomes at 0 1 3 and 6 months after the second injection Three months will be the primary endpoint and six months will be an exploratory unfunded endpoint
LC-PRP Outcomes As this is a feasibility study it is likely that this study will be underpowered for clinical outcomes However the investigators will still monitor pain and the above outcome measures and identify potential time-related improvements
Economic Evaluation The investigators will track staff- time- equipment- and supply-related costs to accurately identify costs associated with each injection This will ensure that costs are accurately recorded
Potential subjects will then be approached by a member of the research team to discuss the consideration of taking part in the study if they meet the inclusion criteria of this study project Using all forms of good clinical practice a member of the study team will review with the participant the Informed Consent Form allow participant to read the informed consent ICF and ask questions prior to signing the ICF Potential subjects may also be asked by other physicians or staff members familiar with the study
Low Cost-Platelet Rich Plasma LC-PRP preparation method See Documents for full details This method follows the same procedures as the standard-of-care FDA-cleared method used by numerous commercial machines thus it does not require additional FDA clearance or approval To summarize the full method in the appendix 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 The investigators will perform a full analysis a complete blood count CBC with differential on subjects whole blood and their prepared LC-PRP Importantly the investigators will include all data required in the PRP minimum reporting standards including platelet differential leukocyte and red cell analysis of all samples Also note that although the investigators are collecting these values for the purposes of the study CBC values are not needed in the community
Injections A total of 20 joints estimated 10-15 patients will receive injections performed at day 0 and 3 weeks for a total of two injections - two injections have demonstrated superior outcomes to one and will increase our number of injections to improve the proof of feasibility All subjects will receive ultrasound-guided intra-articular joint injections by an experienced sports medicine provider after local anesthesia with 1 lidocaine to the extra-articular structures namely the skin and joint capsule to increase comfort Note though the investigators are using ultrasound guidance to ensure that they are guaranteeing accurate injectate placement for this study this is not necessarily required in the community setting These will be performed after the patients typical factor infusions if applicable
Questionnaire The investigators will collect demographic information along with baseline and subsequent functional patient reported outcomes namely the WOMAC knee FAOS ankle and the QuickDASH elbow REDCap will be used to administer surveys and store data The investigators will additionally ask about adverse events pain global satisfaction global injection satisfaction and medications
Data collection time points and follow-up Follow-up data see timeline below will be administered electronically Subjects will be queried by email text message in person andor by telephone regarding treatment outcomes at 0 1 3 and 6 months after the second injection Three months will be the primary endpoint and six months will be an exploratory unfunded endpoint
LC-PRP Outcomes As this is a feasibility study it is likely that this study will be underpowered for clinical outcomes However the investigators will still monitor pain and the above outcome measures and identify potential time-related improvements
Economic Evaluation The investigators will track staff- time- equipment- and supply-related costs to accurately identify costs associated with each injection This will ensure that costs are accurately recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None