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

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

Study Overview

• Status: Completed
• Conditions: Renal Replacement Therapy
• Intervention / Treatment: Procedure: dialysis mode

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; intermittent hemodialysis or continuous renal replacement therapy
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; intermittent hemodialysis or continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication related to bleeding	gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding	24 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Dialysis mode_coagulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No