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

This study is currently recruiting participants.
Verified September 2011 by Institut de Terapia Regenerativa Tissular
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: September 23, 2011
Last verified: September 2011
History of Changes

September 22, 2011
September 23, 2011
October 2009
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01440725 on ClinicalTrials.gov Archive Site
  • Percentage of muscular lesion recurrence. [ Time Frame: During all study (one year of follow-up) ] [ Designated as safety issue: No ]

    Percentatge 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 ]
    Percentatge 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.
Same as current
 
 
 
Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
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)
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Muscle Injuries
  • Biological: Autologous Platelet-rich plasma (PRP)
    4-8cc, a single dose
    Other Names:
    • Platelet-rich plasma
    • Growth factors from platelet-rich plasma
  • Procedure: Evacuation of haematoma
    Evacuation of the haematoma, a single procedure
    Other Name: Drainage of haematoma
  • Experimental: PRP
    Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma.
    Intervention: Biological: Autologous Platelet-rich plasma (PRP)
  • Active Comparator: Evacuation of haematoma
    Evacuation of the hematoma, and simulation of the administration of PRP
    Intervention: Procedure: Evacuation of haematoma
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
December 2012
February 2012   (final data collection date for primary outcome measure)

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, ASA (Aspirin ®) and NSAIDs during the study
Both
18 Years and older
No
Contact: Martínez Zapata, MD, PhD 34 93 553 78 08 mmartinezz@santpau.cat
Contact: Orozco Delclòs, MD, PhD 93 393 31 59 lluis.orozco@itrt.es
Spain
 
NCT01440725
PRP-RICE, ISCIII; Spain
No
Institut de Terapia Regenerativa Tissular
Institut de Terapia Regenerativa Tissular
  • Centro Cochrane Iberoamericano
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
Institut de Terapia Regenerativa Tissular
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP