Blunt Chest TraumaNCT01623921
Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma
A study testing Celecoxib, Rosuvastatin and Combined therapy in people with Blunt Chest Trauma and Acute Respiratory Distress Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blunt Chest Trauma, Acute Respiratory Distress Syndrome
- What is being tested?
- Celecoxib, Rosuvastatin and Combined therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Diagnosis of lung contusion by physical examination, chest xrays, history by the patient, accompanying persons or police.
- Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
- Admission to ward
Who cannot join
- Penetrating trauma
- Current use of lipid-lowering therapy, use of non steroidal anti-inflammatory drugs.
- Current use of postmenopausal hormone-replacement therapy
- Evidence of hepatic dysfunction (an alanine aminotransferase level more than twice the upper limit of the normal range), a creatine kinase level more than three times the upper limit of the normal range.
- Creatinine level higher than 2.0 mg/dl
- Known uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg
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- History of uncontrolled hypothyroidism (thyroid-stimulating hormone level> 1.5 times the upper limit of the normal range)
- Psychiatric disorders
- Pregnancy
- Known allergy or intolerance to one of the protocol drug
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Avi A Weinbroum, MD, 3-6973237 ext. 972, draviw@tasmc.health.gov.il
About this study
Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an important role in the pathogenesis of acute lung injury (ALI).
Aims: The current study aims at evaluating the beneficial effects of statins and COX-2 receptor inhibitors on ALI elicited by blunt trauma to the chest.
Read more
Methods: After approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ED) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space.
Expected results: The investigators expect to find that the proposed treatment will be effective in reducing ALI burden. The investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ALI.
- Being tested
- standard care treatment, Celecoxib, Rosuvastatin, Combined therapy
- Keywords
- Lung, Contusion, Injury, Cyclooxygenase, Statin
- Medical subject headings
- Respiratory Distress Syndrome, Contusions, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard care treatmentDrug
Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
CelecoxibDrug
Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
RosuvastatinDrug
Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
Combined therapyDrug
Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
| Study group | Role | What they receive |
|---|---|---|
| control | Other | Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) Receives: Drug: standard care treatment |
| Celecoxib | Active comparator | Group 2: Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) Receives: Drug: Celecoxib |
| rosuvastatin | Active comparator | Group 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) Receives: Drug: Rosuvastatin |
| Combined therapy | Active comparator | Group 4: Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) Receives: Drug: Combined therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]
- Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] according to following criteria:
- Suspected or proven infection
- Hypoxemia: PaO2/FiO2is ≤300 mm HgBilateral infiltrates consistent with pulmonary edema
- Positive-pressure mechanical ventilation through an endotracheal tube
- No clinical evidence of left atrial hypertension to explain bilateral infiltrates
- Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Chest TraumaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623921
- Sponsor's protocol ID
- TASMC-08-WAA-026911-TLV
- Status last verified
- Jun 2012
- First submitted
- 17 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and Selective Cyclooxygenase-2 Receptor Inhibitors in Blunt Chest Trauma
- ClinicalTrials.gov ID
- NCT01623921
- Acronym / sponsor ID
- TASMC-08-WAA-026911-TLV
- Keywords
- Lung, Contusion, Injury, Cyclooxygenase, Statin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Jun 2012 (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.
Background: Lung contusion affects 17%-25% of adult blunt trauma patients, and is the leading cause of death from blunt thoracic injury. Statins are lipid-lowering drugs with recently suggested anti-inflammatory and antioxidant properties. Cyclo-oxygenase-2 (COX-2) is a key enzyme in the production of prostaglandins (PG), and evidence suggests that COX-2 plays an important role in the pathogenesis of acute lung injury (ALI).
Aims: The current study aims at evaluating the beneficial effects of statins and COX-2 receptor inhibitors on ALI elicited by blunt trauma to the chest.
Methods: After approval by the institutional ethics and a scientific committee, and obtaining informed consent , patients admitted to the emergency department (ED) due to blunt trauma with a diagnosis of lung contusion will be enrolled in the study.The effects of statins and COX 2 inhibitors on ALI will be assessed by recording clinical parameters and measuring inflammatory mediators levels in the serum and in the bronchoalveolar space.
Expected results: The investigators expect to find that the proposed treatment will be effective in reducing ALI burden. The investigators also suppose that using a combination of those drugs will synergistically potentiate their effect on ALI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | Other | Drug: standard care treatmentGroup 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
| Celecoxib | Active comparator | Drug: CelecoxibGroup 2: Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
| rosuvastatin | Active comparator | Drug: RosuvastatinGroup 3: Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
| Combined therapy | Active comparator | Drug: Combined therapyGroup 4: Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years of age
- Diagnosis of lung contusion by physical examination, chest xrays, history by the patient, accompanying persons or police.
- Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
- Admission to ward
Key exclusion criteria (10 listed)
- Penetrating trauma
- Current use of lipid-lowering therapy, use of non steroidal anti-inflammatory drugs.
- Current use of postmenopausal hormone-replacement therapy
- Evidence of hepatic dysfunction (an alanine aminotransferase level more than twice the upper limit of the normal range), a creatine kinase level more than three times the upper limit of the normal range.
- Creatinine level higher than 2.0 mg/dl
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 |
|---|---|---|
| standard care treatmentGroup 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) | Drug | control |
| CelecoxibCelecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) | Drug | Celecoxib |
| RosuvastatinRosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) | Drug | rosuvastatin |
| Combined therapyCombined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal) | Drug | Combined therapy |
Primary outcome
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS]
Time frame: 3 days
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] according to following criteria: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm HgBilateral infiltrates consistent with pulmonary edema 3. Positive-pressure mechanical ventilation through an endotracheal tube 4. No clinical evidence of left atrial hypertension to explain bilateral infiltrates 5. Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celecoxib, Rosuvastatin and Combined therapy in people with Blunt Chest Trauma and Acute Respiratory Distress Syndrome, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 10 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: status not confirmed, as of the sponsor's last update on 20 Jun 2012. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avi A Weinbroum, MD (3-6973237 ext. 972, draviw@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Signs of ALI, i.e., pneumonia, adult respiratory distress syndrome [ARDS] (time frame: 3 days). 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 20 Jun 2012.