- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536195
Impact of Renal Replacement Therapy on Coagulation Profile of Patients with Acute Renal Failure (HEMOSTIR)
March 20, 2025 updated by: University Hospital, Brest
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29609
- CHRU de Brest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.
Description
Inclusion Criteria:
- critically ill patients
- acute renal failure
- renal replacement therapy
- plasmatic urea > 20
Exclusion Criteria:
- chronic renal failure
- platelet count less than 80 Giga
- V factor less than 70%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visco elastometry
Time Frame: Change in ROTEM parameters from baseline to after renal replacement therapy
|
ROTEM (Rotational Thromboelastometry)
|
Change in ROTEM parameters from baseline to after renal replacement therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2018
Primary Completion (Actual)
November 23, 2021
Study Completion (Actual)
November 23, 2021
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (Actual)
May 24, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 20, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Hematologic Diseases
- Hemorrhagic Disorders
- Acute Kidney Injury
- Renal Insufficiency
- Hemorrhage
- Hemostatic Disorders
- Blood Coagulation Disorders
Other Study ID Numbers
- HEMOSTIR (29BRC17.0132)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.