Deep Vein Thrombosis
Conditions
Keywords
Deep vein thrombosis, Children, Pediatric, Anti-coagulant, Neurosurgical procedures, Blood Clot
Brief 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. 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.
Interventions
None listed
Sponsors
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients age 1 month-12 years undergoing elective neurosurgical procedures.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism | within 72 hours after surgery | The number of participants with post-operative ultrasound without evidence of thromboembolism |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| Total | 91 |
Baseline characteristics
| Characteristic | Ultrasound Group (All) | — |
|---|---|---|
| Age, Categorical <=18 years | 91 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Received baseline ultrasound | 91 Participants | — |
| Region of Enrollment United States | 91 participants | — |
| Sex: Female, Male Female | 46 Participants | — |
| Sex: Female, Male Male | 45 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
The number of participants with post-operative ultrasound without evidence of thromboembolism
Time frame: within 72 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound Group (All) | Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism | 91 Participants |