Hemostatic Profiles in Pediatric CKD
Condition: Kidney Disease, Chronic; Pediatric Kidney Disease; Renal Insufficiency, Chronic; Blood Coagulation Disorders in Children
MeSH terms: Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

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.
    

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.
    

Intervention name(s): phlebotomy
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Cross-Sectional
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.
      
Keywords: thromboelastography; TEG; viscoelastic assay