Psoas HematomasNCT03452631
Spontaneous Haematomas of Psoas Occurring in Intensive Care
An observational study of Psoas Hematomas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoas Hematomas
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2017to 31 Dec 2017
- Phase
- Observational
- 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
Study population: Patient with psoas hematoma diagnosed during hospitalization
Who may be able to join
- Major patients
- Psoas hematoma diagnosed during hospitalization
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study
Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.
- Conditions
- Psoas Hematomas
- Keywords
- Psoas hematomas
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of psoas hematomas
Measured: 72 hours after admission to intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Oct 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoas HematomasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie HELMS, MD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452631
- Sponsor's protocol ID
- 6838
- Status last verified
- Jun 2022
- First submitted
- 26 Feb 2018
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Haematomas of Psoas Occurring in Intensive Care: Incidence, Patient Characteristics and Treatment, a Retrospective Study
- ClinicalTrials.gov ID
- NCT03452631
- Acronym / sponsor ID
- 6838
- Conditions
- Psoas Hematomas
- Keywords
- Psoas hematomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 Mar 2018 (actual)
- 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.
Psoas hematomas are a rare and potentially lethal pathology whose incidence in resuscitation is unknown. The pathophysiology of this pathology is not known to date.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with psoas hematoma diagnosed during hospitalization
Key inclusion criteria (2 listed)
- Major patients
- Psoas hematoma diagnosed during hospitalization
Key exclusion criteria (1 listed)
- Refusal to participate in 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.
Primary outcome
Number of psoas hematomas
Time frame: 72 hours after admission to intensive care
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 1 Jul 2022.
- Individual participant dataSharing planned: No
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.
Julie HELMS, MD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoas Hematomas, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 inclusion and 1 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 1 Jul 2022. 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 France. 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?
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?
Number of psoas hematomas (time frame: 72 hours after admission to intensive care). 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 1 Jul 2022.