Compartment SyndromePhase 1NCT00022815
Management of Compartment Syndrome With Ultrafiltration
A Phase 1 study testing Tissue ultrafiltration in people with Compartment Syndrome, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Compartment Syndrome
- What is being tested?
- Tissue ultrafiltration
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jun 2004
- Phase
- Phase 1
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has a closed or open Gustilo grade I, grade II, or grade IIIa tibial shaft fracture that is going to be treated with surgical stabilization under general anesthesia.
- An open fracture must have sufficient skin for wound coverage.
- The patient has a single tibial fracture.
- The patient is mentally alert and able to sign his or her own consent form.
- Patient is at least 60" in height.
- Patient is between 14 and 80 years of age.
Who cannot join
- The patient previously had a fracture in the same leg.
- The patient has a Gustilo grade IIIb open fracture.
- The patient has a Tscherne grade II or Tscherne grade III injury.
- Patients with evidence of compartment syndrome at the time of admission.
- The patient is obese, with body mass index greater than 35 (km/m2).
- Have medical condition(s) that precludes use of indwelling catheters for 24 hours, such as dermatologic conditions or immunological deficits.
- Have co-morbidities that may place the patient at risk of hypotension (e.g., significant blood loss, heart failure, significant chest or abdominal trauma, septicemia, or massive soft tissue trauma).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55405
About this study
This study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. In the legs and other parts of the body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that run next to and through them. The entire unit is called a compartment. The causes of compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle compartment in the injured area of the lower leg. The probes remove fluid from the compartment (extra fluid can cause increased pressure).
We will do an initial safety study in a group of patients who have had surgery for a broken tibia (the inner, larger bone of the lower leg) and are at high risk for developing compartment syndrome. The goals of this initial study are to show that inserting tissue ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly without problems; to show that tissue ultrafiltration can be used to monitor the biochemical environment inside tissues; and to show that the catheter apparatus provides an accurate measurement of pressure in the compartment.
Read the detailed description
The human clinical trials are organized as a series of consecutive studies designed to demonstrate the safety and efficacy of ultrafiltration in the management of compartment syndrome (CS). The first study is a cohort study of patients with tibial shaft fractures that will test the safety of the catheters as well as demonstrate that ultrafiltration fibers provide an improved method for monitoring myofascial compartment physiology. The goals of this study are to (1) demonstrate that inserting ultrafiltration (UF) catheters is safe and reproducible; (2) show that CSUF allows for biochemical assessment of cellular function; and (3) show that the CSUF apparatus provides an accurate measurement of intracompartmental pressure.
The study population will consist of 10 patients with closed or open Gustilo grade I, grade II, or grade IIIa tibial shaft fractures that require surgical stabilization. We will recruit patients for the study at the study centers. Data collected during this study will be numerical values for the biochemical measurements and for the intramuscular pressure (IMP) measurements. We will compare the CSUF system values for intramuscular pressure with IMP measured with a Stryker device. Finally, we will correlate serial changes in the biochemical measures to any changes in IMP. The metabolic assay will show increased UF levels compared to serum levels.
We will consider fasciotomy when the IMP is within 30 mmHg of the patient's diastolic blood pressure, or when the clinical examination of the patient demands. We will make repeat IMP measurements at the time of fasciotomy and record the interval to and reasons for fasciotomy.
Following the operative stabilization of the tibial fracture and before the final closure of any traumatic wounds, we will insert multiple UF catheters into the anterior, lateral, and posterior (superficial and deep) compartments of the leg. Techniques used for catheter insertion will be similar to existing methods for the insertion of drainage catheters and we do not anticipate any specific difficulties with this step.
To measure intramuscular pressure, we will connect one of the catheters designed for this purpose to a standard pressure transducer and will use it to monitor intracompartmental pressure (IMP) in real-time. In addition, we will use a standard wick catheter, inserted separately, for control measurements.
For biochemical measurements, we will analyze samples of the interstitial fluid removed by CSUF for levels of creatine phosphokinase (CPK), lactic acid, lactate dehydrogenase (LDH), osmolarity, pH, and pO2. We will obtain fluid every 4 hours for up to 48 hours. The assays will be performed by standard clinical laboratory techniques.
- Conditions
- Compartment Syndrome
- Being tested
- Tissue ultrafiltration
- Keywords
- Compartment syndrome, Tissue ultrafiltration, Reperfusion injury, Ischemia
- Medical subject headings
- Compartment Syndromes, Reperfusion Injury, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue ultrafiltrationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2001 (estimated)
- Study startJun 2002
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- William Fowler, Principal investigator, Twin Star Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022815
- Sponsor's protocol ID
- R44AR044591
- Other IDs
- NIAMS-062
- Status last verified
- Apr 2008
- First submitted
- 14 Aug 2001
- Last updated
- 14 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Compartment Syndrome With Ultrafiltration
- ClinicalTrials.gov ID
- NCT00022815
- Acronym / sponsor ID
- R44AR044591
- Conditions
- Compartment Syndrome
- Keywords
- Compartment syndrome, Tissue ultrafiltration, Reperfusion injury, Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 16 Aug 2001 (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 study will test the safety of a new treatment method called tissue ultrafiltration. We will test this method in the treatment of compartment syndrome, a condition that occurs when pressure within the muscles builds to dangerous levels. In the legs and other parts of the body, a tough, stiff membrane covers groups of muscles and the nerves and blood vessels that run next to and through them. The entire unit is called a compartment. The causes of compartment syndrome include traumatic leg injuries and loss of blood supply. In tissue ultrafiltration, a doctor places hollow probes, or catheters, directly into the muscle compartment in the injured area of the lower leg. The probes remove fluid from the compartment (extra fluid can cause increased pressure).
We will do an initial safety study in a group of patients who have had surgery for a broken tibia (the inner, larger bone of the lower leg) and are at high risk for developing compartment syndrome. The goals of this initial study are to show that inserting tissue ultrafiltration catheters in the muscle compartment is safe and can be done repeatedly without problems; to show that tissue ultrafiltration can be used to monitor the biochemical environment inside tissues; and to show that the catheter apparatus provides an accurate measurement of pressure in the compartment.
Detailed description
The human clinical trials are organized as a series of consecutive studies designed to demonstrate the safety and efficacy of ultrafiltration in the management of compartment syndrome (CS). The first study is a cohort study of patients with tibial shaft fractures that will test the safety of the catheters as well as demonstrate that ultrafiltration fibers provide an improved method for monitoring myofascial compartment physiology. The goals of this study are to (1) demonstrate that inserting ultrafiltration (UF) catheters is safe and reproducible; (2) show that CSUF allows for biochemical assessment of cellular function; and (3) show that the CSUF apparatus provides an accurate measurement of intracompartmental pressure.
The study population will consist of 10 patients with closed or open Gustilo grade I, grade II, or grade IIIa tibial shaft fractures that require surgical stabilization. We will recruit patients for the study at the study centers. Data collected during this study will be numerical values for the biochemical measurements and for the intramuscular pressure (IMP) measurements. We will compare the CSUF system values for intramuscular pressure with IMP measured with a Stryker device. Finally, we will correlate serial changes in the biochemical measures to any changes in IMP. The metabolic assay will show increased UF levels compared to serum levels.
We will consider fasciotomy when the IMP is within 30 mmHg of the patient's diastolic blood pressure, or when the clinical examination of the patient demands. We will make repeat IMP measurements at the time of fasciotomy and record the interval to and reasons for fasciotomy.
Following the operative stabilization of the tibial fracture and before the final closure of any traumatic wounds, we will insert multiple UF catheters into the anterior, lateral, and posterior (superficial and deep) compartments of the leg. Techniques used for catheter insertion will be similar to existing methods for the insertion of drainage catheters and we do not anticipate any specific difficulties with this step.
To measure intramuscular pressure, we will connect one of the catheters designed for this purpose to a standard pressure transducer and will use it to monitor intracompartmental pressure (IMP) in real-time. In addition, we will use a standard wick catheter, inserted separately, for control measurements.
For biochemical measurements, we will analyze samples of the interstitial fluid removed by CSUF for levels of creatine phosphokinase (CPK), lactic acid, lactate dehydrogenase (LDH), osmolarity, pH, and pO2. We will obtain fluid every 4 hours for up to 48 hours. The assays will be performed by standard clinical laboratory techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The patient has a closed or open Gustilo grade I, grade II, or grade IIIa tibial shaft fracture that is going to be treated with surgical stabilization under general anesthesia.
- An open fracture must have sufficient skin for wound coverage.
- The patient has a single tibial fracture.
- The patient is mentally alert and able to sign his or her own consent form.
- Patient is at least 60" in height.
Key exclusion criteria (7 listed)
- The patient previously had a fracture in the same leg.
- The patient has a Gustilo grade IIIb open fracture.
- The patient has a Tscherne grade II or Tscherne grade III injury.
- Patients with evidence of compartment syndrome at the time of admission.
- The patient is obese, with body mass index greater than 35 (km/m2).
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 |
|---|---|---|
| Tissue ultrafiltration | Device | – |
Primary outcome
Not reported in the source record.
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 14 Apr 2008.
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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.
William Fowler principal investigator
Twin Star Medical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tissue ultrafiltration in people with Compartment Syndrome, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
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 6 inclusion and 7 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 14 Apr 2008. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 14 Apr 2008.