Acute Renal FailureHEMOSTIRNCT03536195
Impact of Renal Replacement Therapy on Coagulation Profile of Patients with Acute Renal Failure
An observational study of Acute Renal Failure and Hemorrhage, run by University Hospital, Brest at 1 site in France.
Trial summary
Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure, Hemorrhage, Coagulation Disorder
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2018to 23 Nov 2021
- 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: Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.
Who may be able to join
- critically ill patients
- acute renal failure
- renal replacement therapy
- plasmatic urea > 20
Who cannot join
- chronic renal failure
- platelet count less than 80 Giga
- V factor less than 70%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Renal Replacement Therapy on Coagulation Profile in Patients with Acute Renal Failure
Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.
- Conditions
- Acute Renal Failure, Hemorrhage, Coagulation Disorder
- Keywords
- renal replacement therapy, acute renal failure, coagulation, bleeding
- Medical subject headings
- Acute Kidney Injury, Hemorrhage, Hemostatic Disorders, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
visco elastometry
ROTEM (Rotational Thromboelastometry)
Measured: Change in ROTEM parameters from baseline to after renal replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start18 Aug 2018
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536195
- Sponsor's protocol ID
- HEMOSTIR (29BRC17.0132)
- Acronym
- HEMOSTIR
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2018
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Renal Replacement Therapy on Coagulation Profile in Patients with Acute Renal Failure
- ClinicalTrials.gov ID
- NCT03536195
- Acronym / sponsor ID
- HEMOSTIR / HEMOSTIR (29BRC17.0132)
- Conditions
- Acute Renal Failure, Hemorrhage, Coagulation Disorder
- Keywords
- renal replacement therapy, acute renal failure, coagulation, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Aug 2018 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 24 May 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.
Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.
Key inclusion criteria (4 listed)
- critically ill patients
- acute renal failure
- renal replacement therapy
- plasmatic urea > 20
Key exclusion criteria (3 listed)
- chronic renal failure
- platelet count less than 80 Giga
- V factor less than 70%
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
visco elastometry
Time frame: Change in ROTEM parameters from baseline to after renal replacement therapy
ROTEM (Rotational Thromboelastometry)
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 24 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Renal Failure and Hemorrhage, run by University Hospital, Brest 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 4 inclusion and 3 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 24 Mar 2025. 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?
visco elastometry (time frame: Change in ROTEM parameters from baseline to after renal replacement therapy). 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 24 Mar 2025.