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Impact of Dialysis Modality on Coagulation and Platelet Function

Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04512131
Enrollment
60
Registered
2020-08-13
Start date
2020-08-04
Completion date
2023-06-30
Last updated
2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Replacement Therapy

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

Detailed description

An prospective observational study will be conducted to confirm the impact of two dialysis modalitites on coagulation and platelet function in critically ill patients requiring renal replacement therapy using laboratory test, Multiplate and ROTEM.

Interventions

PROCEDUREdialysis mode

intermittent hemodialysis or continuous renal replacement therapy

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of changes in CT in EXTEM of ROTEM (seconds)

Secondary

MeasureTime frameDescription
Multiplate® platelet function analysis area under curve unitbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of platelet function using Multiplate®
clot formation time (CFT) in EXTEMbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of CFT in EXTEM using ROTEM (seconds)
Amplitude 10 minutes after CT (A10) in EXTEMbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of A10 in EXTEM using ROTEM (mm)
α-angle in EXTEMbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of α-angle in EXTEM using ROTEM (º)
Maximal clot firmness (MCF) in EXTEMbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of MCF in EXTEM using ROTEM (mm)
prothrombin timebefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of prothrombin time (seconds)
activated partial thromboplastin timebefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of activated partial thromboplastin time (seconds)
Protein Sbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of Protein S
fibrinogenbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of fibrinogen
D-dimerbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of D-dimer
platelet countbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of platelet count
the amount of blood transfusion24 hoursthe amount of blood transfusion for 24 hours after taking second blood sample
hemodynamic changes24 hourschanges of mean arterial pressure \> 20 %, increased vasopressor/inotropics
changes of characteristics or amount of drainage24 hourschanges of characteristics or amount of drainage
Protein Cbefore and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapythe difference of Protein C

Other

MeasureTime frameDescription
complication related to bleeding24 hoursgastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026