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Completed

NCT Number: NCT01440725

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)

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Key information

Conditions

Muscle Injuries Hematoma Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Cochrane Iberoamericano

Barcelona, 08041, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet-Rich Plasma (PRP)

Biological

4-8cc, a single dose

Other names: Platelet-rich plasma, Growth factors from platelet-rich plasma

Evacuation of haematoma

Procedure

Evacuation of the haematoma, a single procedure

Other names: Drainage of haematoma

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of muscular lesion recurrence.

    Time frame: During all study (one year of follow-up)

    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.

  2. Percentage of healing

    Time frame: 8 weeks

    Percentage of patients with the healed lesion

  3. Quality of the regenerated area

    Time frame: at 8 week

    By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)

  4. Pain

    Time frame: 12 months

    The pain will be measured by a VAS each week, the first 8 weeks of the study and, at 6 and 12 month.

  5. 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.

Sponsors and collaborators

Lead sponsor

Institut de Terapia Regenerativa Tissular

Other

Collaborators

  • Asociacion Colaboracion Cochrane Iberoamericana
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Registry information

Official study 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

Acronym: PRP-RICE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 26, 2011
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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