Vascular ThrombosisNCT05889897
Prevalence, Risk Factors and Outcomes of Pediatric Vascular Thrombosis
An observational study of Vascular Thrombosis, run by Assiut University.
Trial summary
This study is aimed to identify the prevalence, risk factors and outcomes of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications . Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Vascular Thrombosis
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jul 2024
- 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 18 years
- All sexes
- Child, Adult
Study population: 15 infant aged from 1 day to 18 years with vascular thrombosis
Who may be able to join
- Age : From 1day to 18 years.
- Sex : Both genders.
- Confirmed diagnosed cases, either Symptomatic or asymptomatic venous and arterial thromboembolism established by an imaging study.
- All patients admitted to the different units of children hospital including surgical unit.
Who cannot join
- Age more than 18 years.
- Patient Known to have Sickle cell disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence, Risk Factors and Outcomes of Vascular Thromboembolism in Children Attending Assuit University Hospital
This study is aimed to identify the prevalence, risk factors and outcomes of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications .
Read the detailed description
Thrombosis is a blood clot that develops within veins or sometimes arteries in the body.
Occur most commonly in the inferior and superior vena cava, their major tributaries, the deep veins of the extremities, the splanchnic veins, as well as the cerebral venous sinuses.
The incidence of venous thromboembolism (VTE) increases with age. In the pediatric population (0-18 years) the incidence is approximately 0.7-2.1 cases per 100,000 children,1-3 while in the adult population the incidence is 100-150 per 100,000.4
Risk factors include the presence of central venous lines, trauma, major surgery followed by bedrest, immobilization, infection (cellulitis, osteomyelitis, phlebitis), cancer chemotherapy, inflammatory bowel disease, nephrotic syndrome, obesity, dehydration, and total parenteral nutrition.
Patients with vascular thromboembolism present with various symptoms depending on site of thrombosis , symptoms include swelling, redness, pain , low-grade fever In cases that develop pulmonary embolism they experience chest pain and shortness of breath that begin suddenly
Diagnosis of vascular thromboembolism include combination of signs and symptoms together with laboratory investigations that include routine lab investigations, D-dimer , protein s , protein C and antithrombin lll also imaging studies as Doppler US , MSCT with angiography and MRV
Vascular thrombosis mainly treated with anticoagulant therapy with subcutaneous injection of low molecular weight heparin These medications prevent the clot from growing and decrease the risk of its breaking apart and causing further complications Other treatments may include wearing compression stockings and applying warm packs to improve blood flow and pain caused by the clot
- Conditions
- Vascular Thrombosis
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pediatrics with vascular thrombosis
This study is aimed to identify the prevalence of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications
Measured: baseline
Number of risk factors of pediatric vascular thrombosis
This study is aimed to identify risk factors of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Sayed Shaker Ahmed, Assiut University
- Investigators
- Maher Mokhtar, Prof, Principal investigator, Assiut UniversityMervat Amin, Assist Prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889897
- Sponsor's protocol ID
- pediatric vascular thrombosis
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Risk Factors and Outcomes of Vascular Thromboembolism in Children Attending Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05889897
- Acronym / sponsor ID
- pediatric vascular thrombosis
- Conditions
- Vascular Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 5 Jun 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.
This study is aimed to identify the prevalence, risk factors and outcomes of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications .
Detailed description
Thrombosis is a blood clot that develops within veins or sometimes arteries in the body.
Occur most commonly in the inferior and superior vena cava, their major tributaries, the deep veins of the extremities, the splanchnic veins, as well as the cerebral venous sinuses.
The incidence of venous thromboembolism (VTE) increases with age. In the pediatric population (0-18 years) the incidence is approximately 0.7-2.1 cases per 100,000 children,1-3 while in the adult population the incidence is 100-150 per 100,000.4
Risk factors include the presence of central venous lines, trauma, major surgery followed by bedrest, immobilization, infection (cellulitis, osteomyelitis, phlebitis), cancer chemotherapy, inflammatory bowel disease, nephrotic syndrome, obesity, dehydration, and total parenteral nutrition.
Patients with vascular thromboembolism present with various symptoms depending on site of thrombosis , symptoms include swelling, redness, pain , low-grade fever In cases that develop pulmonary embolism they experience chest pain and shortness of breath that begin suddenly
Diagnosis of vascular thromboembolism include combination of signs and symptoms together with laboratory investigations that include routine lab investigations, D-dimer , protein s , protein C and antithrombin lll also imaging studies as Doppler US , MSCT with angiography and MRV
Vascular thrombosis mainly treated with anticoagulant therapy with subcutaneous injection of low molecular weight heparin These medications prevent the clot from growing and decrease the risk of its breaking apart and causing further complications Other treatments may include wearing compression stockings and applying warm packs to improve blood flow and pain caused by the clot
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 15 infant aged from 1 day to 18 years with vascular thrombosis
Key inclusion criteria (4 listed)
- Age : From 1day to 18 years.
- Sex : Both genders.
- Confirmed diagnosed cases, either Symptomatic or asymptomatic venous and arterial thromboembolism established by an imaging study.
- All patients admitted to the different units of children hospital including surgical unit.
Key exclusion criteria (2 listed)
- Age more than 18 years.
- Patient Known to have Sickle cell disease.
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
Number of pediatrics with vascular thrombosis
Time frame: baseline
This study is aimed to identify the prevalence of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications
Number of risk factors of pediatric vascular thrombosis
Time frame: Baseline
This study is aimed to identify risk factors of children with either venous or arterial thromboembolism admitted to children hospital Assiut University aiming at early detection and avoidance of catastrophic complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
Maher Mokhtar, Prof principal investigator
Assiut University
Mervat Amin, Assist Prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular 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 4 inclusion and 2 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 18 Jul 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 Doaa sayed (01064884771, nananony551996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pediatrics with vascular thrombosis (time frame: baseline). 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?
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 18 Jul 2023.