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Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma (PRP-RICE)

This study has been completed.
Sponsor:
Collaborators:
Centro Cochrane Iberoamericano
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Institut de Terapia Regenerativa Tissular
ClinicalTrials.gov Identifier:
NCT01440725
First received: September 22, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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)


Condition Intervention Phase
Muscle Injuries
Biological: Autologous Platelet-rich plasma (PRP)
Procedure: Evacuation of haematoma
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Institut de Terapia Regenerativa Tissular:

Primary Outcome Measures:
  • Time to complete recover of muscular lesions [ Time Frame: weekely assessment during 8 weeks ] [ Designated as safety issue: No ]
    The complete recovering will be when the patient does his habitual activity.


Secondary Outcome Measures:
  • Percentage of muscular lesion recurrence. [ Time Frame: During all study (one year of follow-up) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of patients with the healed lesion

  • Quality of the regenerated area [ Time Frame: at 8 week ] [ Designated as safety issue: No ]
    By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)

  • Pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.


Enrollment: 71
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRP
Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
Biological: Autologous Platelet-rich plasma (PRP)
4-8cc, a single dose
Other Names:
  • Platelet-rich plasma
  • Growth factors from platelet-rich plasma
Active Comparator: Evacuation of haematoma
Evacuation of the hematoma, and simulation of the administration of PRP
Procedure: Evacuation of haematoma
Evacuation of the haematoma, a single procedure
Other Name: Drainage of haematoma

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440725

Locations
Spain
Centro Cochrane Iberoamericano
Barcelona, Spain, 08041
Sponsors and Collaborators
Institut de Terapia Regenerativa Tissular
Centro Cochrane Iberoamericano
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
  More Information

No publications provided

Responsible Party: Institut de Terapia Regenerativa Tissular
ClinicalTrials.gov Identifier: NCT01440725     History of Changes
Other Study ID Numbers: PRP-RICE, ISCIII; Spain
Study First Received: September 22, 2011
Last Updated: January 8, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Institut de Terapia Regenerativa Tissular:
muscle
injuries
platelet-rich plasma
autologous
haematoma

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014