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CompletedNCT05064267Updated Sep 21, 2023

Hemostatic Profiles in Pediatric CKD

An observational study in Kidney Disease, Chronic, Pediatric Kidney Disease and Renal Insufficiency, Chronic, sponsored by Children's Healthcare of Atlanta. Completed at 1 site in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Children's Healthcare of Atlanta · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
8
Ages
6 Months to 17 Years
Sex
All
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Study summary

This cross-sectional pilot study will examine the blood clotting patterns in children with chronic kidney disease stages 3, 4, and 5. A total of 30 participants will be enrolled with 10 participants for each stage of chronic kidney disease. Blood specimens will be collected from each participant during a routine clinic visit, and will then be processed to evaluate blood clotting characteristics according to thrombelastography and more conventional clotting tests.

Read the detailed description

Chronic kidney disease (CKD) is associated with 5% of all pediatric inpatient venous thromboembolism (VTE) occurrences, but rates of occurrence are likely underreported in current literature. VTE is associated with a 2-fold increase in mortality, and exponentially higher rates of healthcare expenditure. Because VTE is a low-incidence but high-impact complication of CKD, evaluating those at risk presents a unique challenge. The underlying pathophysiology of thrombosis in CKD is poorly understood, but likely involves changes across the hemostatic and fibrinolytic systems. Standard laboratory tests provide a poor representation of in-vivo clot formation, particularly in the complex hemostatic environment of CKD, as these tests undergo centrifugation and much of the cellular debris known to contribute to clot formation is lost. Viscoelastic assays are a reemerging tool that provide a qualitative measure of each hemostatic milestone, from clot formation through degradation, in whole-blood; thereby preserving the cellular debris and additional factors that contribute to clot formation in-vivo.

The purpose of this study is to evaluate the utility of Thrombelastography vs conventional clotting tests to predict onset of hypercoagulability and the relationship to the stage of pediatric Chronic Kidney Disease (CKD). The investigators hypothesize that as kidney function deteriorates, a more pronounced prothrombotic profile is expected to emerge according to TEG and conventional clotting tests. This will be demonstrated by an overall increase in measured values across the coagulation portion of the TEG and a decrease in the measured fibrinolysis. According to conventional clotting tests, it is expected to find increased levels of Factor VIII antigen, Fibrinogen, vWF, Protein C/S, and D-dimer. Depending upon an individual's degree of proteinuria, levels of Antithrombin would be expected to decrease as it is lost in the urine. This urinary loss of Antithrombin would also contribute to an overall prothrombotic profile.

This cross-sectional pilot study will enroll 30 participants between the ages of 6 months and 17 years who have been previously diagnosed with CKD stages 3, 4, or 5. Enrollment will occur during a routine clinic visit wherein the participant was also previously scheduled to receive venipuncture for ongoing monitoring of labs. Study specific lab values, in addition to routine lab values of interest and pertinent past medical history, will be extracted from the EMR.

02

Conditions studied

  • Kidney Disease, Chronic
  • Pediatric Kidney Disease
  • Renal Insufficiency, Chronic
  • Blood Coagulation Disorders in Children

Keywords

  • thromboelastography
  • TEG
  • viscoelastic assay
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 8 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Children's Healthcare of Atlanta is the lead sponsor of 95 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Previously established, and routinely followed, pediatric individuals between the ages of 6 months and 17 years with a non-inflammatory etiology of chronic kidney disease staged as 3, 4, or 5.

Inclusion criteria

  • Pediatric patients ages 6 months - 17 years
  • Currently followed in the CKD clinic at Children's Healthcare of Atlanta (CHOA)
  • Diagnosed with Stage 3, Stage 4 or Stage 5 CKD
  • Must have routine venous laboratory tests planned as a component of their clinic encounter.

Exclusion criteria

Exclusion Criteria:

  • Participants \<13.6kg (to allow for safe blood sample volumes).
  • History of venous thromboembolism, post solid organ transplant, co-diagnosis of inflammatory disease, and nephritis.
  • Personal or family history of inherited thrombophilia conditions
  • Hospital admission within the last 30 days.
  • Transfusion (PRBC, FFP, Platelets, or Cryoprecipitate) within the last 30 days.
  • Those on the following medications: steroids and anti-coagulants.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • CKD stage 3

    Between the ages of 6 months and 17 years currently followed within the hospital system's CKD clinic, and diagnosed with CKD 3 from a non-inflammatory etiology.

    Diagnostic Test: phlebotomy

  • CKD stage 4

    Between the ages of 6 months and 17 years currently followed within the hospital system's CKD clinic, and diagnosed with CKD 4 from a non-inflammatory etiology.

    Diagnostic Test: phlebotomy

  • CKD stage 5

    Between the ages of 6 months and 17 years currently followed within the hospital system's CKD clinic, and diagnosed with CKD 5 from a non-inflammatory etiology.

    Diagnostic Test: phlebotomy

Interventions

  • Diagnostic testphlebotomy

    phlebotomy will be performed to obtain coagulation labs of interest. Specifically, in addition to standard clinical labs, the following will be drawn on study participants: thrombelastography with platelet mapping, antithrombin, DIC panel, factor VIII, vWF antigen, Protein C antigen and activity, Protein S antigen and activity, and ferritin.

06

What researchers measure

Primary outcomes

  1. Degree of statistically-significant correlation between conventional clotting tests and thrombelastography when determining the degree of hypercoagulability for pediatric patients diagnosed with chronic kidney disease stages 3, 4, and 5

    Thrombelastography with platelet mapping, antithrombin, vwF, Factor VIII antigen, DIC panel, Protein C activity and antigen, Protein S activity and antigen, and Ferritin labs will be evaluated in each participant from the 3 CKD groups.

    Time frame: Day 1

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Study locations

1 site
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05064267
Lead sponsor
Children's Healthcare of Atlanta
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Nov 15, 2021
Primary completion
May 10, 2022
Completion
May 10, 2022
Last update
Sep 21, 2023

Study contacts

Christina Calamaro, PhD
principal investigator · Children's Healthcare of Atlanta

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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