NCT04512131

Brief Summary

The investigators will evaluate the impact of dialysis modality (intermittent hemodialysis or continuous renal replacement therapy) in coagulation and platelet function in critically ill patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2020

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

August 4, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

2.6 years

First QC Date

August 4, 2020

Last Update Submit

December 20, 2023

Conditions

Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)

    the difference of changes in CT in EXTEM of ROTEM (seconds)

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

Secondary Outcomes (15)

  • Multiplate® platelet function analysis area under curve unit

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

  • clot formation time (CFT) in EXTEM

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

  • Amplitude 10 minutes after CT (A10) in EXTEM

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

  • α-angle in EXTEM

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

  • Maximal clot firmness (MCF) in EXTEM

    before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy

  • +10 more secondary outcomes

Other Outcomes (1)

  • complication related to bleeding

    24 hours

Study Arms (2)

Intermittent hemodialysis

patients who are going to undergo intermittent hemodialysis or patients who are going to switch dialysis mode to intermittent hemodialysis from continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate® platelet function analysis will be checked just before dialysis initiation and immediately after dialysis termination

Procedure: dialysis mode

continuous renal replacement therapy

patients who are going to undergo continuous renal replacement therapy Laboratory test including complete blood count, prothrombin time, activated partial thromboplastin time, protein C, protein S and D-dimer, EXTEM of ROTEM and Multiplate platelet function analysis will be checked within 24 hours after dialysis initiation and 48 hours after taking first blood sample

Procedure: dialysis mode

Interventions

dialysis modePROCEDURE

intermittent hemodialysis or continuous renal replacement therapy

Intermittent hemodialysiscontinuous renal replacement therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

critically ill adult patients in surgical intensive care unit requiring renal replacement therapy

You may qualify if:

  • Critically ill adult patients in surgical intensive care unit who require renal replacement therapy

You may not qualify if:

  • Patients treated with anti-coagulation therapy due to thrombosis/embolism
  • Patients who take anti-platelet drug due to cardiac or cerebrovascular diseased
  • Patients treated with pharmacological prophylaxis of deep vein thrombosis
  • Patients who received blood products within 24 hours of dialysis initiation
  • Patients who do not want life-sustaining care including renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 13, 2020

Study Start

August 4, 2020

Primary Completion

February 27, 2023

Study Completion

June 30, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

KR(1)