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NCT Number: NCT04512131

Impact of Dialysis Modality on Coagulation and Platelet Function

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

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Key information

Conditions

Renal Replacement Therapy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dialysis mode

Procedure

intermittent hemodialysis or continuous renal replacement therapy

Primary outcomes

  1. clotting time (CT) in EXTEM in rotational thromboelastometry (ROTEM)

    Time frame: 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 outcomes

  1. Multiplate® platelet function analysis area under curve unit

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 24 hours

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

  14. hemodynamic changes

    Time frame: 24 hours

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

  15. changes of characteristics or amount of drainage

    Time frame: 24 hours

    changes of characteristics or amount of drainage

Other outcomes

  1. complication related to bleeding

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 13, 2020
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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