NCT03536195

Brief 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. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 18, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

April 25, 2018

Last Update Submit

March 20, 2025

Conditions

Acute Renal FailureHemorrhageCoagulation Disorder

Keywords

renal replacement therapyacute renal failurecoagulationbleeding

Outcome Measures

Primary Outcomes (1)

  • visco elastometry

    ROTEM (Rotational Thromboelastometry)

    Change in ROTEM parameters from baseline to after renal replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.

You may qualify if:

  • critically ill patients
  • acute renal failure
  • renal replacement therapy
  • plasmatic urea \> 20

You may not qualify if:

  • chronic renal failure
  • platelet count less than 80 Giga
  • V factor less than 70%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Acute Kidney InjuryHemorrhageHemostatic DisordersThrombosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and Thrombosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 24, 2018

Study Start

August 18, 2018

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)