Back to resultsEfficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma (PRP-RICE)
Primary Purpose
Muscle Injuries
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Autologous Platelet-rich plasma (PRP)
Evacuation of haematoma
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Injuries focused on measuring muscle, injuries, platelet-rich plasma, autologous, haematoma
Eligibility Criteria
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
Sites / Locations
- Centro Cochrane Iberoamericano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRP
Evacuation of haematoma
Arm Description
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
Evacuation of the hematoma, and simulation of the administration of PRP
Outcomes
Primary Outcome Measures
Time to complete recover of muscular lesions
The complete recovering will be when the patient does his habitual activity.
Secondary Outcome Measures
Percentage of muscular lesion recurrence.
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.
Percentage of healing
Percentage of patients with the healed lesion
Quality of the regenerated area
By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
Pain
The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.
Adverse effects to treatments
Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.
Full Information
NCT ID
NCT01440725
First Posted
September 22, 2011
Last Updated
January 8, 2013
Sponsor
Institut de Terapia Regenerativa Tissular
Collaborators
Asociacion Colaboracion Cochrane Iberoamericana, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT01440725
Brief Title
Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
Acronym
PRP-RICE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Terapia Regenerativa Tissular
Collaborators
Asociacion Colaboracion Cochrane Iberoamericana, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Injuries
Keywords
muscle, injuries, platelet-rich plasma, autologous, haematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP
Arm Type
Experimental
Arm Description
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
Arm Title
Evacuation of haematoma
Arm Type
Active Comparator
Arm Description
Evacuation of the hematoma, and simulation of the administration of PRP
Intervention Type
Biological
Intervention Name(s)
Autologous Platelet-rich plasma (PRP)
Other Intervention Name(s)
Platelet-rich plasma, Growth factors from platelet-rich plasma
Intervention Description
4-8cc, a single dose
Intervention Type
Procedure
Intervention Name(s)
Evacuation of haematoma
Other Intervention Name(s)
Drainage of haematoma
Intervention Description
Evacuation of the haematoma, a single procedure
Primary Outcome Measure Information:
Title
Time to complete recover of muscular lesions
Description
The complete recovering will be when the patient does his habitual activity.
Time Frame
weekely assessment during 8 weeks
Secondary Outcome Measure Information:
Title
Percentage of muscular lesion recurrence.
Description
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.
Time Frame
During all study (one year of follow-up)
Title
Percentage of healing
Description
Percentage of patients with the healed lesion
Time Frame
8 weeks
Title
Quality of the regenerated area
Description
By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
Time Frame
at 8 week
Title
Pain
Description
The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.
Time Frame
12 months
Title
Adverse effects to treatments
Description
Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martínez Zapata, Mª José
Organizational Affiliation
Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orozco Delclòs, LLuís
Organizational Affiliation
Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cochrane Iberoamericano
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
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