NCT05899283

Brief Summary

This study exploring the expression characteristics of different cells of peripheral blood after exposure to two kinds of hemodialysis filter membrane materials will help to elucidate the key mechanisms of hemodialysis filter coagulation occurrence, which is an important guideline for reducing the occurrence of adverse events in hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

January 31, 2023

Last Update Submit

June 1, 2023

Conditions

Uremia

Keywords

Hemodialysis FilterOCI-HF160FX800HDF

Outcome Measures

Primary Outcomes (2)

  • Filter coagulation grade 3

    Filter coagulation grade 3 is a severe clotting events

    4 hours

  • Filter multiplexer residual volume <0.8

    Filter multiplexer residual volume \<0.8 is also a severe clotting events

    4 hours

Secondary Outcomes (9)

  • Blood platelets

    4 hours

  • Hemoglobin

    4 hours

  • Leukocytes

    4 hours

  • Blood coagulation factor TF

    4 hours

  • Blood coagulation factor FXII

    4 hours

  • +4 more secondary outcomes

Study Arms (2)

Group A(OCI-HF160+FX800HDF)

EXPERIMENTAL

Group A first used the hemodialysis filter OCI-HF160, then used FX800HDF.

Device: OCI-HF160Device: FX800HDF

Group B(FX800HDF+OCI-HF160)

EXPERIMENTAL

Group B first used the hemodialysis filter FX800HDF, and then used OCI-HF160.

Device: OCI-HF160Device: FX800HDF

Interventions

OCI-HF160DEVICE

OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.

Also known as: the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160
Group A(OCI-HF160+FX800HDF)Group B(FX800HDF+OCI-HF160)
FX800HDFDEVICE

FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.

Also known as: the Fresenius Hemodialysis Filter FX80
Group A(OCI-HF160+FX800HDF)Group B(FX800HDF+OCI-HF160)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years, gender not limited;
  • Patients with clinical diagnosis of chronic renal insufficiency (CKD stage 5) requiring renal replacement therapy;
  • Dialysis access was central venous catheter;
  • Newly placed tubing, not dialysed patients; (5) patients voluntarily participated and written informed consent signed by the patient or authorized delegate had been obtained.

You may not qualify if:

  • Patients with acute renal failure;
  • Patients are participating in other clinical studies;
  • Pregnancy or breastfeeding;
  • Use of hemostatic or anticoagulant drugs in the last 1 week;
  • Positive infectious serum markers for HIV, syphilis, hepatitis B, and hepatitis C;
  • Presence of active infection;
  • Allergy to dialyzers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

June 12, 2023

Study Start

March 1, 2021

Primary Completion

July 31, 2021

Study Completion

October 30, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

CN(1)