Kidney Disease, ChronicNCT05064267
Hemostatic Profiles in Pediatric CKD
An observational study of Kidney Disease, Chronic and Pediatric Kidney Disease, run by Children's Healthcare of Atlanta at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Kidney Disease, Chronic, Pediatric Kidney Disease, Renal Insufficiency, Chronic
- What is being tested?
- phlebotomy
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 10 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
About this study
Official title: Evaluation of Thrombelastography vs. Non-Viscoelastic Assays to Predict Hypercoagulability in Pediatric Chronic Kidney Disease: A Pilot Study
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.
- Conditions
- Kidney Disease, Chronic, Pediatric Kidney Disease, Renal Insufficiency, Chronic, Blood Coagulation Disorders in Children
- Being tested
- phlebotomy
- Keywords
- thromboelastography, TEG, viscoelastic assay
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phlebotomyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Nov 2021
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Calamaro, PhD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064267
- Sponsor's protocol ID
- STUDY00000777
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thrombelastography vs. Non-Viscoelastic Assays to Predict Hypercoagulability in Pediatric Chronic Kidney Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05064267
- Acronym / sponsor ID
- STUDY00000777
- Conditions
- Kidney Disease, Chronic, Pediatric Kidney Disease, Renal Insufficiency, Chronic, Blood Coagulation Disorders in Children
- Keywords
- thromboelastography, TEG, viscoelastic assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD stage 3 | – | Diagnostic Test: phlebotomyBetween 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. |
| CKD stage 4 | – | Diagnostic Test: phlebotomyBetween 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. |
| CKD stage 5 | – | Diagnostic Test: phlebotomyBetween 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. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phlebotomyphlebotomy 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. | Diagnostic test | CKD stage 3, CKD stage 4, CKD stage 5 |
Primary outcome
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
Time frame: Day 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Calamaro, PhD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, Chronic and Pediatric Kidney Disease, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 28 Oct 2026.