Hemostatic Profiles in Pediatric CKD

NCT05064267 | Completed

• 1 other identifier: STUDY00000777
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

thromboelastography; TEG; viscoelastic assay

Outcome Measures

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.

  Day 1

Study Arms (3)

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

phlebotomy DIAGNOSTIC_TEST

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.

CKD stage 3; CKD stage 4; CKD stage 5

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christina Calamaro, PhD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: November 15, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)