Hemostatic Profiles in Pediatric CKD

Renal Insufficiency, Chronic Clinical Trial

Official title:

Evaluation of Thrombelastography vs. Non-Viscoelastic Assays to Predict Hypercoagulability in Pediatric Chronic Kidney Disease: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064267
• Other study ID #: STUDY00000777
• Status: Completed
• Start date: November 15, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: September 2023
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Kidney Disease, Chronic
• Kidney Diseases
• Pediatric Kidney Disease
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• phlebotomy
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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