NCT01440725

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

3.2 years

First QC Date

September 22, 2011

Last Update Submit

January 8, 2013

Conditions

Muscle Injuries

Keywords

muscleinjuriesplatelet-rich plasmaautologoushaematoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Percentage of muscular lesion recurrence.

    During all study (one year of follow-up)

  • Percentage of healing

    8 weeks

  • Quality of the regenerated area

    at 8 week

  • Pain

    12 months

  • Adverse effects to treatments

    12 months

Study Arms (2)

PRP

EXPERIMENTAL

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)

Evacuation of haematoma

ACTIVE COMPARATOR

Evacuation of the hematoma, and simulation of the administration of PRP

Procedure: Evacuation of haematoma

Interventions

Autologous Platelet-rich plasma (PRP)BIOLOGICAL

4-8cc, a single dose

Also known as: Platelet-rich plasma, Growth factors from platelet-rich plasma
PRP
Evacuation of haematomaPROCEDURE

Evacuation of the haematoma, a single procedure

Also known as: Drainage of haematoma
Evacuation of haematoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of bleeding disorders
  • Inability to follow-up the patient
  • The use of corticosteroids, acetylsalicylic acid(Aspirin ®) and nonsteroidal antiinflammatory drugs during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cochrane Iberoamericano

Barcelona, Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Wounds and InjuriesHematoma

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 26, 2011

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

ES(1)