Thromboelastographic Profile in Healthy Newborns and Infants of Diabetic Mothers Using TEG6s

NCT04917965 | Unknown

• 1 other identifier: 262407
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Thromboelastography (TEG) is a laboratory technique used to examine the process of clot formation and degradation by measuring and reporting the kinetic changes, the rate of clot formation, clot strength, and clot stability. TEG provides numeric values and a graphical representation of the primary and secondary hemostatic systems and fibrinolysis more quickly and with a smaller blood sample than routine coagulation studies. TEG6s, the newest TEG platform, simplifies and standardizes TEG technique and is currently available at only four US children's hospitals. Normative values of TEG6s results have not been established in healthy neonates. There are a number of well-established perinatal risk factors for thrombosis in the newborn; however, maternal diabetes has been the most frequently identified risk factor in the newborn since 1965. Despite the well-established hypercoagulable state observed in infants of diabetic mothers (IDMs), there have been no studies evaluating TEG in IDMs. To establish normative data and investigate the hypercoagulable state of IDMs, this observational prospective cohort study will evaluate TEG6s in these two populations: a control group that will include neonates ≥37 weeks gestational age born to mothers with uncomplicated pregnancies and a comparison group that will include neonates ≥37 weeks born to mothers with gestational diabetes or a history of Type 1 or Type 2 diabetes prior to pregnancy, either requiring insulin or diet controlled. We hypothesize that cord blood TEG6s results will differ between healthy newborns and IDMs reflecting a hypercoagulable state in IDMs with an increased coagulation index (CI) in the IDM group. A sample size calculation was performed for a two-sample t-test using the POWER procedure in SAS version 9.4. Based on a two-tailed alpha of 0.05 and a standard deviation of 0.9, the total N was determined to be 40 (i.e., 20 in each group). This yields a power of 0.84 to detect a difference of 1.25 units in the mean CI between IDMs and healthy controls. To avoid blood loss and skin breaking procedures in the subjects, umbilical cord blood obtained from the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital, where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Statistical analyses will be performed on the results of these studies and will provide normative data in healthy newborns and infants of diabetic mothers. Having data on the coagulation profile of neonates will help guide management techniques and help explain the propensity to clot among IDMs and guide further research into prevention and treatment of this complication.

Conditions

Thromboelastography; Coagulation; Fetus or Newborn; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes, Gestational

Keywords

thromboelastography; infant of diabetic mother; coagulation profile

Outcome Measures

Primary Outcomes (1)

• Coagulation Index

  The coagulation index composed of the various components from TEG6s will be calculated and analyzed by a statistician

  Data will be obtained at time of delivery on day of life 1

Study Arms (2)

Healthy Term Neonates

Infants born at 37 weeks gestational age or greater born to mothers of any age with uncomplicated pregnancies. Following delivery, cord blood obtained from the placental portion of the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Specimens will be transported utilizing Specimen Transport Guidelines.

Other: Laboratory clotting studies

Term infants of diabetic mothers

Infants born at 37 weeks gestational age or greater to mothers of any age with gestational diabetes or Type 1 or Type 2 diabetes, managed with either diet or insulin. Following delivery, cord blood obtained from the placental portion of the umbilical cord will be used for analysis. To assure appropriate dilution, a hematocrit will be measured at the time of blood collection using a blood gas machine for prompt results. Sample blood will immediately be taken by the investigators from the delivery hospital to the children's hospital where the following clotting studies will be performed: PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s. Specimens will be transported utilizing Specimen Transport Guidelines.

Other: Laboratory clotting studies

Interventions

Laboratory clotting studies OTHER

Cord blood will be utilized to perform lab test including PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s

Healthy Term Neonates; Term infants of diabetic mothers

Eligibility Criteria

• Age: 0 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mothers delivering or scheduled to deliver at the Labor and Delivery unit at UAMS when study personnel are available will be approached to discuss participation if they meet criteria for enrollment. A control group will include neonates ≥37 weeks gestational age on day of life 1 born to mothers with uncomplicated pregnancies and a comparison group that will include neonates ≥37 weeks gestational age on day of life 1 born to mothers with gestational diabetes or a history of Type 1 or Type 2 diabetes prior to pregnancy, either requiring insulin or diet controlled. The control group will include 20 subjects, and the comparison group will include 20 subjects.

You may qualify if:

• Control Group: Healthy term neonates
• Infants born at 37 weeks gestational age or greater born to mothers of any age with uncomplicated pregnancies
• Comparison Group: Term infants of diabetic mothers
• Infants born at 37 weeks gestational age or greater to mothers of any age with gestational diabetes or Type 1 or Type 2 diabetes, managed with either diet or insulin

You may not qualify if:

• For Both Groups:
• Infants \<37 weeks gestational age
• Multiple gestation pregnancies
• Maternal thrombocytopenia
• Known fetal anomalies
• Known maternal blood clotting disorders or history of thrombosis
• Known family history of clotting disorders
• Chorioamnionitis (diagnosed prior to delivery)
• For "Healthy Term Neonates"
• Intrauterine growth restriction
• Gestational hypertension, chronic hypertension, pre-eclampsia, and/or eclampsia
• Any other major complication of pregnancy or major medical history

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (7)

• Edwards RM, Naik-Mathuria BJ, Gay AN, Olutoye OO, Teruya J. Parameters of thromboelastography in healthy newborns. Am J Clin Pathol. 2008 Jul;130(1):99-102. doi: 10.1309/LABNMY41RUD099J2.

  PMID: 18550478 BACKGROUND

• Sidlik R, Strauss T, Morag I, Shenkman B, Tamarin I, Lubetsky A, Livnat T, Kenet G. Assessment of Functional Fibrinolysis in Cord Blood Using Modified Thromboelastography. Pediatr Blood Cancer. 2016 May;63(5):839-43. doi: 10.1002/pbc.25865. Epub 2016 Jan 8.

  PMID: 26749087 BACKGROUND

• Sewell EK, Forman KR, Wong EC, Gallagher M, Luban NL, Massaro AN. Thromboelastography in term neonates: an alternative approach to evaluating coagulopathy. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F79-F84. doi: 10.1136/archdischild-2016-310545. Epub 2016 May 13.

  PMID: 27178714 BACKGROUND

• Erdoes G, Schloer H, Eberle B, Nagler M. Next generation viscoelasticity assays in cardiothoracic surgery: Feasibility of the TEG6s system. PLoS One. 2018 Dec 20;13(12):e0209360. doi: 10.1371/journal.pone.0209360. eCollection 2018.

  PMID: 30571781 BACKGROUND

• Lloyd-Donald P, Churilov L, Zia F, Bellomo R, Hart G, McCall P, Martensson J, Glassford N, Weinberg L. Assessment of agreement and interchangeability between the TEG5000 and TEG6S thromboelastography haemostasis analysers: a prospective validation study. BMC Anesthesiol. 2019 Mar 30;19(1):45. doi: 10.1186/s12871-019-0717-7.

  PMID: 30927909 BACKGROUND

• Sarkar S, Hagstrom NJ, Ingardia CJ, Lerer T, Herson VC. Prothrombotic risk factors in infants of diabetic mothers. J Perinatol. 2005 Feb;25(2):134-8. doi: 10.1038/sj.jp.7211222.

  PMID: 15526010 BACKGROUND

• Oppenheimer EH, Esterly JR. Thrombosis in the newborn: comparison between infants of diabetic and nondiabetic mothers. J Pediatr. 1965 Oct;67(4):549-56. doi: 10.1016/s0022-3476(65)80424-3. No abstract available.

  PMID: 5319226 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alexandra G Woodle, MD

  ACHRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra G Woodle, MD

CONTACT

9548161411; agwoodle@uams.edu

David Matlock, MD

CONTACT

3184589097; dmatlock@uams.edu

Study Design

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

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: August 1, 2021
• Primary Completion: January 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (1)