Impact of Dialysis Modality on Coagulation and Platelet Function

Completed

• Conditions: Renal Replacement Therapy
• Interventions: Procedure: dialysis mode

• Registration Number: NCT04512131
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2020-08-04
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-13
• Primary Completion: 2023-02-27
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
continuous renal replacement therapy	dialysis mode	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
Intermittent hemodialysis	dialysis mode	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

Primary Outcome Measures

Name	Time	Method
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 therapy	the difference of changes in CT in EXTEM of ROTEM (seconds)

Secondary Outcome Measures

Name	Time	Method
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	the difference of platelet function using Multiplate®
Protein S	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of Protein S
platelet count	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of platelet count
the amount of blood transfusion	24 hours	the amount of blood transfusion for 24 hours after taking second blood sample
hemodynamic changes	24 hours	changes of mean arterial pressure \> 20 %, increased vasopressor/inotropics
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	the difference of CFT in EXTEM using ROTEM (seconds)
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	the difference of A10 in EXTEM using ROTEM (mm)
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	the difference of MCF in EXTEM using ROTEM (mm)
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	the difference of α-angle in EXTEM using ROTEM (º)
prothrombin time	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of prothrombin time (seconds)
activated partial thromboplastin time	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of activated partial thromboplastin time (seconds)
fibrinogen	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of fibrinogen
Protein C	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of Protein C
D-dimer	before and after applying each mode of dialysis (4 hours in intermittent hemodialysis and 48 hours in continuous renal replacement therapy	the difference of D-dimer
changes of characteristics or amount of drainage	24 hours	changes of characteristics or amount of drainage

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of