- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440725
Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma (PRP-RICE)
Multicenter Double Blind, With Evaluator Blinding, Parallel, Randomized Clinical Trial, to Assess the Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
This is a multicenter, simple blind, masking of outcomes assessors, parallel, randomised clinical trial in patient with muscle rupture and with hematoma production. The main hypothesis is that infiltration in the area of muscle injury in autologous platelet-rich plasma (PRP)improves muscle regeneration and repair by shortening the time to complete recovery.
The main objective is to evaluate the PRP for healing muscular lesions 'tennis leg' type or distal rectus femoral. The secondary objectives are: to evaluate the risk of lesion recurrence; to evaluate the quality of lesion recovery process and evaluate intervention's safety.
Experimental treatment will be the administration of PRP autologous (4-8 cc in a unique dose) by muscular infiltration en the empty space generated after the hematoma evacuation. Control treatment will be hematoma evacuation. Both treatment groups will use compressive bandage and they will recommend rest, extremity elevation, local ice and lately physiotherapy.
Size sample: 76 patients (38 in each group)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain, 08041
- Centro Cochrane Iberoamericano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults over 18 years
- Lesion with haematoma at the Gastrocnemius muscle or the lower portion of the rectus femoral muscle
- Acceptance to participate at the clinical trial
- Not indicated the surgical treatment of the muscle injury
Exclusion criteria
- Patients who do not meet the inclusion criteria
- History of bleeding disorders
- Inability to follow-up the patient
- The use of corticosteroids, acetylsalicylic acid(Aspirin ®) and nonsteroidal antiinflammatory drugs during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PRP
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
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4-8cc, a single dose
Other Names:
|
ACTIVE_COMPARATOR: Evacuation of haematoma
Evacuation of the hematoma, and simulation of the administration of PRP
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Evacuation of the haematoma, a single procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete recover of muscular lesions
Time Frame: weekely assessment during 8 weeks
|
The complete recovering will be when the patient does his habitual activity.
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weekely assessment during 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of muscular lesion recurrence.
Time Frame: During all study (one year of follow-up)
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Percentage of patients with muscular lesion recurrence. Muscular lesion recurrence will be considered if there are symptoms and a lesion gap by ultra sound scan. |
During all study (one year of follow-up)
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Percentage of healing
Time Frame: 8 weeks
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Percentage of patients with the healed lesion
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8 weeks
|
Quality of the regenerated area
Time Frame: at 8 week
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By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
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at 8 week
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Pain
Time Frame: 12 months
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The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.
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12 months
|
Adverse effects to treatments
Time Frame: 12 months
|
Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.
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12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martínez Zapata, Mª José, Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
- Principal Investigator: Orozco Delclòs, LLuís, Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP-RICE
- ISCIII; Spain (OTHER_GRANT: PI080724)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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