Transfusion Requirements During Spinal Surgery for Severe Scoliosis
An Observational Prospective Study of Transfusion Requirements During Spinal Surgery for Severe Scoliosis
1 other identifier
observational
50
1 country
1
Brief Summary
Corrective surgery for scoliosis can result in prolonged operating room time and significant blood loss. The investigators goal is to determine what the transfusion requirements are for young adults undergoing spinal surgery for scoliosis and what other intra-operative factors influence the amount of blood and blood products used. The investigators will used the information obtained to improve the management of patients undergoing corrective surgery for scoliosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 13, 2013
November 1, 2013
3.9 years
December 8, 2011
November 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
transfusion requirements
number of blood transfusion subject required from surgical start time to 72 hours post op
0-72 hours
Secondary Outcomes (1)
vertebral levels fused
intraoperatively
Other Outcomes (3)
operative time
time in OR
ICU stay
days
hospital days
days
Study Arms (1)
scoliosis
young adults requiring surgical correction
Eligibility Criteria
all patients undergoing surgical correction of scoliosis
You may qualify if:
- all patients undergoing surgical correction of scoliosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Newark, New Jersey, 07101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anuradha Patel, MD
UMDNJ/NJMS
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesia/Investigator initiated
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 12, 2011
Study Start
August 1, 2009
Primary Completion
July 1, 2013
Study Completion
November 1, 2013
Last Updated
November 13, 2013
Record last verified: 2013-11