Portal Vein ThrombosisNCT06150807
Portal Vein Thrombosis in Neonate With Umbilical Catheter
An observational study of Portal Vein Thrombosis, run by Assiut University.
Trial summary
The aim of this study is to identify incidence of portal vein thrombosis after umbilical catheter and to identify the risk factor of this condition ,location of PVT and prognosis of PVT. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- ultrasound and doppler
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 30 Jan 2025
- 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 to 28 days
- All sexes
- Child
Study population: all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates <28-day chronological age.
Who may be able to join
- the study population: all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates <28-day chronological age.
Who cannot join
- Neonate who has PVT but not had UVC before .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Frequency and Risk Factors of Portal Vein Thrombosis in Neonate With Umbilical Catheter
The aim of this study is to identify incidence of portal vein thrombosis after umbilical catheter and to identify the risk factor of this condition ,location of PVT and prognosis of PVT.
Read the detailed description
The use of umbilical venous catheters (UVCs) in the neonatal period may be associated with severe complications including the occurrence of portal vein thrombosis (PVT )(1) The placement of an umbilical venous catheter (UVC) is a common procedure in neonatology and has multiple clinical indications driven by the need for quick and secure access for medication administration. Umbilical venous catheters allow quick access for administering drugs, blood products, fluids and parenteral nutrition to acutely ill neonates; however, they are have many complications. The most common complication is nosocomial sepsis ranging from 3% to 16%, followed by thromboembolism and catheter malposition in the heart, great vessels or portal system(2,3) The diagnosis is made by abdominal Doppler ultrasonography . In the cases with portal venous thrombosis, the location, extent, and size of the thrombus were recorded occlusive was defined by hyperechogenic thrombus replacing the entire lumen and no-flow in color Doppler or Partial which defined by non-occlusive hyperechogenic intraluminal thrombus and persistent stream in color Doppler.(4) A prospective observational study of newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital ,neonates who had undergo UVC for any cause between 10/2023 to 9/2024 will enroll in these study with serial ultrasonography of the UVC to determine the incidence and location of thrombi in infants after umbilical catheterization.
All cases included in the study will be evaluated by Birth weight, gender, gestational age, type of catheter, duration of catheter use, types of infused fluids, and location of the catheter tips (UVC), Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins, hepatic veins, splenic vein, and superior mesenteric vein will done in the Department of Pediatric Diagnostic Imaging by a radiologist after removal of the catheter and in case of PVT subsequent serial U/S will preformed until clot resolution.
- Conditions
- Portal Vein Thrombosis
- Being tested
- ultrasound and doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound and dopplerDevice
Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins, hepatic veins, splenic vein, and superior mesenteric vein will done in the Department of Pediatric
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and risk factors of portal vein thrombosis in neonate with umbilical catheter
Identify incidence of portal vein thrombosis after umbilical catheter,Identify the risk factor of this condition ,location of PVT and prognosis of PVT.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start20 Dec 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
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 Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa mostafa ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150807
- Sponsor's protocol ID
- portal vein thrombosis
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salimi M. Comparison of beta-adrenoceptor blocking properties of sotalol, oxprenolol, propranolol and pindolol on rabbit intestinal smooth muscle. Pharmacology. 1975;13(5):441-7. doi: 10.1159/000136936.
PubMed 1802
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Risk Factors of Portal Vein Thrombosis in Neonate With Umbilical Catheter
- ClinicalTrials.gov ID
- NCT06150807
- Acronym / sponsor ID
- portal vein thrombosis
- Conditions
- Portal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 29 Nov 2023 (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 aim of this study is to identify incidence of portal vein thrombosis after umbilical catheter and to identify the risk factor of this condition ,location of PVT and prognosis of PVT.
Detailed description
The use of umbilical venous catheters (UVCs) in the neonatal period may be associated with severe complications including the occurrence of portal vein thrombosis (PVT )(1) The placement of an umbilical venous catheter (UVC) is a common procedure in neonatology and has multiple clinical indications driven by the need for quick and secure access for medication administration. Umbilical venous catheters allow quick access for administering drugs, blood products, fluids and parenteral nutrition to acutely ill neonates; however, they are have many complications. The most common complication is nosocomial sepsis ranging from 3% to 16%, followed by thromboembolism and catheter malposition in the heart, great vessels or portal system(2,3) The diagnosis is made by abdominal Doppler ultrasonography . In the cases with portal venous thrombosis, the location, extent, and size of the thrombus were recorded occlusive was defined by hyperechogenic thrombus replacing the entire lumen and no-flow in color Doppler or Partial which defined by non-occlusive hyperechogenic intraluminal thrombus and persistent stream in color Doppler.(4) A prospective observational study of newborns, who were admitted to the Neonatal intensive care Unit Assiut University Children's Hospital ,neonates who had undergo UVC for any cause between 10/2023 to 9/2024 will enroll in these study with serial ultrasonography of the UVC to determine the incidence and location of thrombi in infants after umbilical catheterization.
All cases included in the study will be evaluated by Birth weight, gender, gestational age, type of catheter, duration of catheter use, types of infused fluids, and location of the catheter tips (UVC), Ultrasound examinations of the liver and spleen including color Doppler imaging of the portal veins, hepatic veins, splenic vein, and superior mesenteric vein will done in the Department of Pediatric Diagnostic Imaging by a radiologist after removal of the catheter and in case of PVT subsequent serial U/S will preformed until clot resolution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates <28-day chronological age.
Key inclusion criteria (1 listed)
- the study population: all neonates with UVC, who will admitted to the Neonatal intensive care Unit Assiut University Children's Hospital had undergo UVC for any cause between 10/2023 to 9/2024 limited to diagnosis established in neonates <28-day chronological age.
Key exclusion criteria (1 listed)
- Neonate who has PVT but not had UVC before .
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 |
|---|---|---|
| ultrasound and dopplerUltrasound examinations of the liver and spleen including color Doppler imaging of the portal veins, hepatic veins, splenic vein, and superior mesenteric vein will done in the Department of Pediatric | Device | – |
Primary outcome
Frequency and risk factors of portal vein thrombosis in neonate with umbilical catheter
Time frame: baseline
Identify incidence of portal vein thrombosis after umbilical catheter,Identify the risk factor of this condition ,location of PVT and prognosis of PVT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 1802Salimi M. Comparison of beta-adrenoceptor blocking properties of sotalol, oxprenolol, propranolol and pindolol on rabbit intestinal smooth muscle. Pharmacology. 1975;13(5):441-7. doi: 10.1159/000136936.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis, run by Assiut 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esraa mostafa (01092686005, Esraa25197@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and risk factors of portal vein thrombosis in neonate with umbilical catheter (time frame: baseline). 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 NCT06150807, 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 6 Dec 2023.