Deep Vein ThrombosisNCT02037607
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
An observational study of Deep Vein Thrombosis, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.
Who may be able to join
- Patients age 1 month-12 years undergoing elective neurosurgical procedures.
Who cannot join
- Patients undergoing outpatient neurosurgical procedures
- Patients with known DVT
- Patients with known hypercoagulable state
- Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)
Trial locations and contacts
1 site in 1 country.
United States1 site
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Children, Pediatric, Anti-coagulant, Neurosurgical procedures, Blood Clot
- Medical subject headings
- Venous Thrombosis, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
The number of participants with post-operative ultrasound without evidence of thromboembolism
Measured: within 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Indiana 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Fulkerson, Indiana University
- Investigators
- Daniel H Fulkerson, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037607
- Sponsor's protocol ID
- 1208009386
- Status last verified
- Sep 2017
- First submitted
- 14 Jan 2014
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scherer AG, White IK, Shaikh KA, Smith JL, Ackerman LL, Fulkerson DH. Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger. J Neurosurg Pediatr. 2017 Jul;20(1):71-76. doi: 10.3171/2017.3.PEDS16588. Epub 2017 May 5.
PubMed 28474980
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
- ClinicalTrials.gov ID
- NCT02037607
- Acronym / sponsor ID
- 1208009386
- Conditions
- Deep Vein Thrombosis
- Keywords
- Deep vein thrombosis, Children, Pediatric, Anti-coagulant, Neurosurgical procedures, Blood Clot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.
Key inclusion criteria (1 listed)
- Patients age 1 month-12 years undergoing elective neurosurgical procedures.
Key exclusion criteria (4 listed)
- Patients undergoing outpatient neurosurgical procedures
- Patients with known DVT
- Patients with known hypercoagulable state
- Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)
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 Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
Time frame: within 72 hours after surgery
The number of participants with post-operative ultrasound without evidence of thromboembolism
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28474980Scherer AG, White IK, Shaikh KA, Smith JL, Ackerman LL, Fulkerson DH. Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger. J Neurosurg Pediatr. 2017 Jul;20(1):71-76. doi: 10.3171/2017.3.PEDS16588. Epub 2017 May 5.
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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.
Daniel H Fulkerson, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Indiana University at 1 site in United States.
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 4 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 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism (time frame: within 72 hours after surgery). 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 NCT02037607, 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 20 Oct 2017.