Impact of Dialysis Modality on Coagulation and Platelet Function

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04512131
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 34.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Renal Replacement Therapy	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Impact of Dialysis Modality on Coagulation and Platelet Function in Critically Ill Patients: Intermittent Hemodialysis vs. Continuous Renal Replacement Therapy
• Actual Study Start Date: Aug 4, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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®

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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)

8. 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

9. 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

10. 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

11. 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

12. 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

13. the amount of blood transfusion [24 hours]

    the amount of blood transfusion for 24 hours after taking second blood sample

14. hemodynamic changes [24 hours]

    changes of mean arterial pressure > 20 %, increased vasopressor/inotropics

15. changes of characteristics or amount of drainage [24 hours]

    changes of characteristics or amount of drainage

Other Outcome Measures

1. complication related to bleeding [24 hours]

   gastrointestinal bleeding-hematochezia/melena, intra-abdominal bleeding, airway bleeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ho Geol Ryu, Associate professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04512131
• Other Study ID Numbers: Dialysis mode_coagulation
• First Posted: Aug 13, 2020
• Last Update Posted: Dec 16, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No

Study Results

No Results Posted as of Dec 16, 2020