Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels

February 28, 2023 updated by: H. Tolga Çelik, Hacettepe University

The Relationship of Ductus Arteriosus Closure and D-Dimer and Fibrinogen Levels in Premature Babies

The aim of this study is to investigate whether there is a relationship between echocardiographic measurements regarding closure of PDA and serum D-Dimer and Fibrinogen levels in premature infants born before 32nd gestational week and weighing less than 1500 grams.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ductus arteriosus (DA) is located between the main pulmonary artery and descending aorta in embryonal life, with dense spiral-located smooth muscle cells in the media layer, and the intima layer is thicker than the aorta. It must be open in fetal life; in this way, the blood flowing from the right ventricle to the collapsed lungs is directed to the descending aorta. DA usually closes "functionally" by constriction of the media during the first three days after labor. In the second week after birth; endothelial folding, subendothelial proliferation and coagulation processes results in "anatomical" permanent closure.

When not closed, patent ductus arteriosus (PDA) is formed resulting in shunting from aorta to pulmonary artery. Probability of patency is inversely related with birth weight. Risk of pulmonary edema, pulmonary hemorrhage, bronchopulmonary dysplasia and loss of pulmonary function increases due to increased pulmonary flow from left to right shunt. Renal, mesenteric and cranial blood supply are impaired due to reduced peripheral circulation. As a result, impaired renal function and necrotizing enterocolitis may develop. Risk of intracranial hemorrhage, cerebral hypoxia and premature retinopathy due to variable blood supply. It has been associated with increased mortality in newborns due to increased morbidity. On physical examination, hyperdynamic precordium, viable pulses and left ventricular hypertrophy are observed. Large PDAs are characterized by prominent pulmonary conus, increased pulmonary vascularization and cardiomegaly on telecardiography.

Diagnosis of PDA is confirmed by echocardiography. Symptomatic PDA treatment and follow-up is mostly followed by echocardiography. Detailed echocardiographic examination can only be performed by a Pediatric Cardiologist, but it is not possible to evaluate DA at any time. It is necessary to benefit from significant changes in specific hematological parameters that may accompany DA closure in order to detect and predict these conditions.

One of the main mechanisms involved in anatomic permanent closure in DA is platelet aggregation and coagulation. To the best of our knowledge, there is no study in the literature investigating whether there is a relationship between Fibrinogen and D-dimer levels and anatomical closure of DA. It is postulated that circulating fibrinogen levels will decrease and D-dimer levels increase as a by-product due to thrombosis in the lumen during DA closure. It is predicted that in infants in whom DA does not close and remain open, fibrinogen levels will be higher and D-dimer levels will be lower than infants in whom DA is closed. It is also suggested that echocardiographic DA measurements will correlate with serum Fibrinogen and D-Dimer levels.

The aim of this study is to investigate whether there is a relationship between echocardiographic measurements regarding closure of PDA and serum D-Dimer and Fibrinogen levels in premature infants born before 32nd gestational week and weighing less than 1500 grams.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

otherwise healthy premature newborns born before 32nd gestational week and weighing less than 1500 grams.

Description

Inclusion Criteria:

premature newborns born before 32nd gestational week and weighing less than 1500 grams.

Exclusion Criteria:

Babies with:

  • Major congenital anomalies
  • Chromosomal anomalies
  • Inborn errors of metabolism
  • Hypoxic ischemic encephalopathy
  • Disseminated intravascular coagulation
  • Unstable hemodynamic status
  • Severe neonatal sepsis
  • Who died in time frame of postnatal 14 days
  • Patients who are not volunteered to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
Premature newborns born before 32nd gestational week and weighing less than 1500 grams.
Diagnostic test: Withdrawal of blood samples for D-Dimer
Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for D-dimer levels.
Diagnostic test: Withdrawal of blood samples for Fibrinogen
Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for Fibrinogen levels.
Diagnostic test: Echocardiographic Examination
At postnatal 3rd, 7th and 14th days, Ductus Arteriosus will be echocardiographically examined to obtain calculations and confirm status of ductal patency or closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rise in D-dimer blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days
Time Frame: postnatal 0 - 14 days
It is postulated that circulating D-dimer levels will increase gradually as a by-product due to thrombosis in the lumen during DA closure from postnatal day 0 to postnatal 3rd and 7th days. It is predicted that D-dimer levels will be lower in infants in whom DA does not close than in infants whom DA is closed. Blood samples are withdrawn accordingly at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for D-dimer levels.
postnatal 0 - 14 days
Fall in Fibrinogen blood levels during Ductus Arteriosus closure from postnatal day 0 to postnatal 3rd and 7th days
Time Frame: postnatal 0 - 14 days
It is postulated that circulating fibrinogen levels will fall gradually due to thrombosis in the lumen during DA closure from postnatal day 0 to postnatal 3rd and 7th days. It is predicted that fibrinogen levels will be higher in infants in whom DA does not close than in infants whom DA is closed. Blood samples are withdrawn accordingly at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for fibrinogen levels.
postnatal 0 - 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-19033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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