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: Completed
• Conditions: Muscle Injuries
• Intervention / Treatment: Biological: Autologous Platelet-rich plasma (PRP); Procedure: Evacuation of haematoma

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Centro Cochrane Iberoamericano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	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 Names: Drainage of haematoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete recover of muscular lesions	The complete recovering will be when the patient does his habitual activity.	weekely assessment during 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During all study (one year of follow-up)
Percentage of healing	Percentage of patients with the healed lesion	8 weeks
Quality of the regenerated area	By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)	at 8 week
Pain	The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.	12 months
Adverse effects to treatments	Adverse effects will be assessed each week, the first 8 weeks of the study and, at 6 and 12 month.	12 months

Collaborators and Investigators

• Sponsor: Institut de Terapia Regenerativa Tissular
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Asociacion Colaboracion Cochrane Iberoamericana
• 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: October 1, 2009
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: September 23, 2011
• First Posted (ESTIMATE): September 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: muscle; autologous; platelet-rich plasma; injuries; haematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Rupture; Hematoma; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: PRP-RICE; ISCIII; Spain (OTHER_GRANT: PI080724)