Muscle InjuriesPhase 3PRP-RICENCT01440725
Efficacy of Platelet Rich Plasma for Treatment of Muscle Rupture With Haematoma
A Phase 3 study testing Autologous Platelet-rich plasma (PRP) and Evacuation of haematoma in people with Muscle Injuries, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Injuries
- What is being tested?
- Autologous Platelet-rich plasma (PRP) and Evacuation of haematoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2009to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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)
- Conditions
- Muscle Injuries
- Being tested
- Autologous Platelet-rich plasma (PRP), Evacuation of haematoma
- Keywords
- muscle, injuries, platelet-rich plasma, autologous, haematoma
- Medical subject headings
- Wounds and Injuries, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-rich plasma (PRP)Biological
Also called Platelet-rich plasma, Growth factors from platelet-rich plasma
4-8cc, a single dose
Evacuation of haematomaProcedure or surgery
Also called Drainage of haematoma
Evacuation of the haematoma, a single procedure
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma. Receives: Biological: Autologous Platelet-rich plasma (PRP) |
| Evacuation of haematoma | Active comparator | Evacuation of the hematoma, and simulation of the administration of PRP Receives: Procedure: Evacuation of haematoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete recover of muscular lesions
The complete recovering will be when the patient does his habitual activity.
Measured: weekely assessment during 8 weeks
Secondary outcomes (5)
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.
Measured: During all study (one year of follow-up)
Percentage of healing
Percentage of patients with the healed lesion
Measured: 8 weeks
Quality of the regenerated area
By ultrasonography, the characteristics of the wound will be quantified (size, fibrosis)
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Terapia Regenerativa Tissular
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Colaboracion Cochrane Iberoamericana, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Responsible party
- Sponsor
- Investigators
- Martínez Zapata, Mª José, Principal investigator, Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant PauOrozco Delclòs, LLuís, Principal investigator, Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440725
- Sponsor's protocol ID
- PRP-RICE
- Other IDs
- ISCIII; Spain
- Acronym
- PRP-RICE
- Status last verified
- Jan 2013
- First submitted
- 22 Sep 2011
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01440725
- Acronym / sponsor ID
- PRP-RICE / PRP-RICE
- Conditions
- Muscle Injuries
- Keywords
- muscle, injuries, platelet-rich plasma, autologous, haematoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Institut de Terapia Regenerativa TissularUniversity, hospital or other
- Collaborators
- Asociacion Colaboracion Cochrane Iberoamericana, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: Autologous Platelet-rich plasma (PRP)Administration of 4-8cc of autologous Platelet-rich plasma (PRP)into the muscle wound after the evacuation of the haematoma. |
| Evacuation of haematoma | Active comparator | Procedure: Evacuation of haematomaEvacuation of the hematoma, and simulation of the administration of PRP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-rich plasma (PRP)Also: Platelet-rich plasma, Growth factors from platelet-rich plasma4-8cc, a single dose | Biological | PRP |
| Evacuation of haematomaAlso: Drainage of haematomaEvacuation of the haematoma, a single procedure | Procedure or surgery | Evacuation of haematoma |
Primary outcome
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.
5 secondary outcomes
Percentage of muscular lesion recurrence.
Time frame: During all study (one year of follow-up)
Percentage of healing
Time frame: 8 weeks
Quality of the regenerated area
Time frame: at 8 week
Pain
Time frame: 12 months
Adverse effects to treatments
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martínez Zapata, Mª José principal investigator
Centro Cochrane Iberoamericano. Servicio de Epidemiología Clínica y Salud Pública. IIB Sant Pau
Orozco Delclòs, LLuís principal investigator
Institut de Teràpia Regenerativa i Tissular. Centro Médico Teknon. Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Platelet-rich plasma (PRP) and Evacuation of haematoma in people with Muscle Injuries, run by Institut de Terapia Regenerativa Tissular at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete recover of muscular lesions (time frame: weekely assessment during 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.