Venous Thromboembolismpediatric DVTNCT01140386
Prevalence and Risk Factors of Venous Thromboembolism in Hospitalized Pediatric Patients
An observational study of Venous Thromboembolism and Deep Venous Thrombosis, run by Penn State University.
Trial summary
The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized pediatric patients, and to identify if there are subgroups of patients who may be at higher risk. There are two hypotheses that will be looked at in this study. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis, Pediatrics
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Mar 2010
- 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 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases: 1. Vascular lab duplex ultrasound database 2. Inpatient hospital admission/discharge ICD-9 database 3. PTSF pediatric trauma database
Who may be able to join
- Age <18
- Hospitalized for greater than or equal to 24 hours
- VTE documented during hospital admission
Who cannot join
- Age >18
About this study
The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized pediatric patients, and to identify if there are subgroups of patients who may be at higher risk.
There are two hypotheses that will be looked at in this study. The first hypothesis is that individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity, black race, female sex, presence of a central venous line (CVL), traumatic mechanism of injury, orthopaedic surgery, and use of oral contraceptives.
The second hypothesis is that risk factors have an additive effect such that risk stratification can be developed to identify those patients with the highest risk.
Read the detailed description
Venous thromboembolism is a well recognized concern in the hospitalized adult population: 11-15% of medically ill adults will have venous thromboembolism (VTE) and 4-5% will develop a proximal DVT in the absence of prophylaxis.6 Furthermore, these diagnosed events are an underestimation of the prevalence of VTE as 80% are clinically silent.6 VTE risk stratification exists for adult populations and prophylaxis against VTE is standard procedure. While VTE occurs less frequently in pediatric populations, the incidence is on a rise. Vu et al report a significant increase in DVT in 2003 compared to 1997 using data from the Health Care Cost and Utilization Project Kids' Inpatient Database. 2 If one were to extrapolate the known adult risk factors for VTE to children, this rise could be attributed to an increase in childhood obesity ,4 an increase in estrogen-based therapy among teenage girls1, or the increase in pediatric trauma.3 However, few studies have been performed to show if these or other identified adult risk factors are indeed pediatric risk factors as well. Due to this lack of knowledge of risk factors for VTE in pediatric populations, there are minimal guidelines for when physicians should provide prophylactic treatment or even have heightened awareness of the possibility of VTE in their pediatric patient. Furthermore, there are scant published guidelines regarding which type of prophylactic treatment is safe and efficacious in the pediatric population, nor are there guidelines regarding the treatment of established VTE. Outcomes of prophylactic treatment will not be able to be evaluated accurately until the measures are undertaken in patients with identified high risk. Identification of high risk groups and subsequent prevention of VTE is important due to the significant morbidity and mortality associated with VTE. Vu et al report a two-fold increase in in-hospital death in pediatric patients with an identified VTE compared to those without one. This risk was independent of other comorbid conditions.2 Morbidity includes pulmonary embolism, recurrent thrombosis, and postphlebitic syndrome (characterized by swelling, pain, skin indurations and pigmentation caused by incompetent venous valves). Due to the younger age of onset, pediatric patients with these morbidities live with the consequences for a much longer period of time; furthermore, they may experience secondary consequence such as limb length discrepancies, etc.
Currently there is a sharp delineation in prophylaxis strategy as defined merely by age. As soon as a patient is 18 he is assessed by risk stratification models and given prophylaxis if he meets these criteria. A patient just one year younger, however, is left unevaluated due to the lack of criteria for VTE risk in pediatric patients. The patient may fit height and weight averages of a full grown adult, and may possess many of the criteria used to assess an adult for VTE risk. He still may not be offered prophylaxis treatment due to his age alone. This assumes age is the best predictive factor of VTE in the younger patient. However, few studies have been done assessing what risk factors truly exist for the pediatric patient, and those that have, suggest that there are other factors that play into the equation, and may even be more important.5 Due to potential complications from both VTE as well as prophylaxis, and the increasing prevalence of VTE in pediatric populations, studies regarding risk factors and safety/efficacy of prophylactic treatment are needed to establish guidelines of care.
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pediatrics
- Keywords
- venous thromboembolism, duplex ultrasound, pediatric population, Vascular lab duplex ultrasound database, Inpatient hospital admission/discharge ICD-9 database, PTSF pediatric trauma database
- Medical subject headings
- Venous Thromboembolism, Venous 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 |
|---|---|---|
| hospital pediatric patients 1/1/2000-12/31/2008 documented VTE | Age <18 Hospitalized for greater than or equal to 24 hours VTE documented during hospital admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
documented deep vein thrombosis (DVT)
Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases:
- Vascular lab duplex ultrasound database
- Inpatient hospital admission/discharge ICD-9 database
- PTSF pediatric trauma database
Measured: 1/1/200 - 12/31/2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
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 Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Penn State 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
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140386
- Sponsor's protocol ID
- 30835
- Acronym
- pediatric DVT
- Status last verified
- Jun 2010
- First submitted
- 8 Jun 2010
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Department of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nchs/data/series/sr_23/sr23_024.pdf 2. L.T. Vu, K.K. Nobuhara, and H. Lee et al., Determination of risk factors for deep venous thrombosis in hospitalized children. Journal of Pediatric Surgery 43 (2008), pp 1095-1099. 3. M.S. Vavilala, A.B. Nathens and G.J. Jurkovich et al., Risk factors for venous thromboembolism in pediatric trauma, J Trauma 52 (2002), pp. 922-927 4. National Health and Nutrition Exam Survey (NHANES); Dept of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nccdphp/dnpa/obesity/childhood/prevalence.htm 5. P.D. Stein, F. Kayali and R.E Olson et al. Incidence of venous thromboembolism in infants and children: Data from the National Hospital Discharge Survey, The Journal of Pediatrics 145 (2004), pp 563-565. 6. R. Pendleton, M. Wheeler, and G. Rodgers. Venous Thromboembolism Prevention in the Acutely Ill Medical Patient: A Review of the Literature and Focus on Special Patient Populations, American Journal of Hematology 79 (2005), pp 229-237.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Venous Thromboembolism in Hospitalized Pediatric Patients
- ClinicalTrials.gov ID
- NCT01140386
- Acronym / sponsor ID
- pediatric DVT / 30835
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pediatrics
- Keywords
- venous thromboembolism, duplex ultrasound, pediatric population, Vascular lab duplex ultrasound database, Inpatient hospital admission/discharge ICD-9 database, PTSF pediatric trauma database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Jun 2010 (estimated)
- 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 issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized pediatric patients, and to identify if there are subgroups of patients who may be at higher risk.
There are two hypotheses that will be looked at in this study. The first hypothesis is that individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity, black race, female sex, presence of a central venous line (CVL), traumatic mechanism of injury, orthopaedic surgery, and use of oral contraceptives.
The second hypothesis is that risk factors have an additive effect such that risk stratification can be developed to identify those patients with the highest risk.
Detailed description
Venous thromboembolism is a well recognized concern in the hospitalized adult population: 11-15% of medically ill adults will have venous thromboembolism (VTE) and 4-5% will develop a proximal DVT in the absence of prophylaxis.6 Furthermore, these diagnosed events are an underestimation of the prevalence of VTE as 80% are clinically silent.6 VTE risk stratification exists for adult populations and prophylaxis against VTE is standard procedure. While VTE occurs less frequently in pediatric populations, the incidence is on a rise. Vu et al report a significant increase in DVT in 2003 compared to 1997 using data from the Health Care Cost and Utilization Project Kids' Inpatient Database. 2 If one were to extrapolate the known adult risk factors for VTE to children, this rise could be attributed to an increase in childhood obesity ,4 an increase in estrogen-based therapy among teenage girls1, or the increase in pediatric trauma.3 However, few studies have been performed to show if these or other identified adult risk factors are indeed pediatric risk factors as well. Due to this lack of knowledge of risk factors for VTE in pediatric populations, there are minimal guidelines for when physicians should provide prophylactic treatment or even have heightened awareness of the possibility of VTE in their pediatric patient. Furthermore, there are scant published guidelines regarding which type of prophylactic treatment is safe and efficacious in the pediatric population, nor are there guidelines regarding the treatment of established VTE. Outcomes of prophylactic treatment will not be able to be evaluated accurately until the measures are undertaken in patients with identified high risk. Identification of high risk groups and subsequent prevention of VTE is important due to the significant morbidity and mortality associated with VTE. Vu et al report a two-fold increase in in-hospital death in pediatric patients with an identified VTE compared to those without one. This risk was independent of other comorbid conditions.2 Morbidity includes pulmonary embolism, recurrent thrombosis, and postphlebitic syndrome (characterized by swelling, pain, skin indurations and pigmentation caused by incompetent venous valves). Due to the younger age of onset, pediatric patients with these morbidities live with the consequences for a much longer period of time; furthermore, they may experience secondary consequence such as limb length discrepancies, etc.
Currently there is a sharp delineation in prophylaxis strategy as defined merely by age. As soon as a patient is 18 he is assessed by risk stratification models and given prophylaxis if he meets these criteria. A patient just one year younger, however, is left unevaluated due to the lack of criteria for VTE risk in pediatric patients. The patient may fit height and weight averages of a full grown adult, and may possess many of the criteria used to assess an adult for VTE risk. He still may not be offered prophylaxis treatment due to his age alone. This assumes age is the best predictive factor of VTE in the younger patient. However, few studies have been done assessing what risk factors truly exist for the pediatric patient, and those that have, suggest that there are other factors that play into the equation, and may even be more important.5 Due to potential complications from both VTE as well as prophylaxis, and the increasing prevalence of VTE in pediatric populations, studies regarding risk factors and safety/efficacy of prophylactic treatment are needed to establish guidelines of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospital pediatric patients 1/1/2000-12/31/2008 documented VTE | – | –Age <18 Hospitalized for greater than or equal to 24 hours VTE documented during hospital admission |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases: 1. Vascular lab duplex ultrasound database 2. Inpatient hospital admission/discharge ICD-9 database 3. PTSF pediatric trauma database
Key inclusion criteria (3 listed)
- Age <18
- Hospitalized for greater than or equal to 24 hours
- VTE documented during hospital admission
Key exclusion criteria (1 listed)
- Age >18
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
documented deep vein thrombosis (DVT)
Time frame: 1/1/200 - 12/31/2008
Patients aged <18 years old, who were hospitalized at MSHMC from January 1, 2000 -December 31, 2008 with documented VTE in one of three databases: 1. Vascular lab duplex ultrasound database 2. Inpatient hospital admission/discharge ICD-9 database 3. PTSF pediatric trauma database
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 24 Nov 2017.
- Results publicationDepartment of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nchs/data/series/sr_23/sr23_024.pdf 2. L.T. Vu, K.K. Nobuhara, and H. Lee et al., Determination of risk factors for deep venous thrombosis in hospitalized children. Journal of Pediatric Surgery 43 (2008), pp 1095-1099. 3. M.S. Vavilala, A.B. Nathens and G.J. Jurkovich et al., Risk factors for venous thromboembolism in pediatric trauma, J Trauma 52 (2002), pp. 922-927 4. National Health and Nutrition Exam Survey (NHANES); Dept of Health and Human Services, Centers for Disease Control and Prevention: http://www.cdc.gov/nccdphp/dnpa/obesity/childhood/prevalence.htm 5. P.D. Stein, F. Kayali and R.E Olson et al. Incidence of venous thromboembolism in infants and children: Data from the National Hospital Discharge Survey, The Journal of Pediatrics 145 (2004), pp 563-565. 6. R. Pendleton, M. Wheeler, and G. Rodgers. Venous Thromboembolism Prevention in the Acutely Ill Medical Patient: A Review of the Literature and Focus on Special Patient Populations, American Journal of Hematology 79 (2005), pp 229-237.
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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.
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 Venous Thromboembolism and Deep Venous Thrombosis, run by Penn State 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 3 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 24 Nov 2017. 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?
documented deep vein thrombosis (DVT) (time frame: 1/1/200 - 12/31/2008). 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 NCT01140386, 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 24 Nov 2017.