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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism | The number of participants with post-operative ultrasound without evidence of thromboembolism | within 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel H Fulkerson, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Whitcomb Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28474980 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Group (All) | All subjects in the study are in the same group. Study procedure is ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
91 subjects received study procedures and were analyzed. 9 additional subjects were consented but withdrawn prior to completion of study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Group (All) | All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism | The number of participants with post-operative ultrasound without evidence of thromboembolism | Posted | Count of Participants | Participants | within 72 hours after surgery |
|
|
Adverse event data was not collected as this was a minimal risk study
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound Group (All) | All subjects in the study are in the same group. Study procedure is ultrasound |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Cero, Research Nurse Manager | Indiana University | 317-396-1298 | hcero@iupui.edu |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Received baseline ultrasound | Count of Participants | Participants |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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