ThrombosisNCT05367466
Risk Factors of Neonatal Thrombosis
An observational study of Thrombosis, run by Kırıkkale University.
Trial summary
The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Thrombosis
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 10 Apr 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 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: All newborns in NICU during 5 year period
Who may be able to join
- All newborn accepted at NICU
Who cannot join
- No
About this study
Official title: Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience
The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different.
In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.
Read the detailed description
All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study.
Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).
The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations
- Conditions
- Thrombosis
- Keywords
- newborn, hereditary risk factors
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newborn with thrombossis | All admitted newborns in NICU during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis in the neonatal period is multifactorial
Measured: January 2022
Hereditary thrombophilia factors also should be thought
Measured: January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jan 2014
- Primary completion30 Dec 2019
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies 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
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilufer Guzoglu, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367466
- Sponsor's protocol ID
- 2022.03.38
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guzoglu N, Albayrak M, Aliefendioglu D. Evaluation of Patients with Neonatal Thrombosis. Indian J Pediatr. 2023 Jun;90(6):615-617. doi: 10.1007/s12098-023-04497-w. Epub 2023 Mar 2.
PubMed 36859514
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience
- ClinicalTrials.gov ID
- NCT05367466
- Acronym / sponsor ID
- 2022.03.38
- Conditions
- Thrombosis
- Keywords
- newborn, hereditary risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 10 May 2022 (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.
The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different.
In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.
Detailed description
All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study.
Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).
The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn with thrombossis | – | –All admitted newborns in NICU during the study period |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All newborns in NICU during 5 year period
Key inclusion criteria (1 listed)
- All newborn accepted at NICU
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombosis in the neonatal period is multifactorial
Time frame: January 2022
Hereditary thrombophilia factors also should be thought
Time frame: January 2022
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 10 May 2022.
- Derived from this study: PubMed 36859514Guzoglu N, Albayrak M, Aliefendioglu D. Evaluation of Patients with Neonatal Thrombosis. Indian J Pediatr. 2023 Jun;90(6):615-617. doi: 10.1007/s12098-023-04497-w. Epub 2023 Mar 2.
- Individual participant dataSharing planned: Undecided
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombosis, run by Kırıkkale University.
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 1 inclusion and 1 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 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Thrombosis in the neonatal period is multifactorial (time frame: January 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367466, which also lists 1 linked publication.
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 10 May 2022.