Transfusion Requirements During Spinal Surgery for Severe Scoliosis
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Purpose
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.
| Condition |
|---|
|
Scoliosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | An Observational Prospective Study of Transfusion Requirements During Spinal Surgery for Severe Scoliosis |
- transfusion requirements [ Time Frame: 0-72 hours ] [ Designated as safety issue: No ]number of blood transfusion subject required from surgical start time to 72 hours post op
- vertebral levels fused [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]number of vertebral levels fused
- operative time [ Time Frame: time in OR ] [ Designated as safety issue: No ]surgical start and finish times
- ICU stay [ Time Frame: days ] [ Designated as safety issue: No ]number of stays subject stays in ICU
- hospital days [ Time Frame: days ] [ Designated as safety issue: No ]number of days until discharge
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
scoliosis
young adults requiring surgical correction
|
Detailed Description:
Data collected prior to surgery will include patients' past medical history, hemoglobin concentration, INR, MCV, gender, age and weight.
Immediately prior to surgery, but after induction of anesthesia, subjects will have another complete blood count drawn to assess preoperative hemoglobin/hematocrit concentrations. This is customarily done to establish a baseline. During surgery patient's core temperature, hemoglobin, hematocrit levels, estimated blood loss, Central Venous Pressure, blood pressure, heart rate, cell saver, the amount of irrigation fluid, colloid, crystalloid, blood and blood products will be recorded hourly throughout surgery. All of the data collection described is standard in these types of cases.
Patients will be transfused allogenic blood if hemoglobin levels fall below 8.0 g/dL or patients present with clinical signs/symptoms of hypovolemia (hypotension, tachycardia). Data collection concerning allogenic blood transfusion will include intraoperative transfusion rate, volume of transfused units per patient and transfusion index. Surgical intervention data regarding the extent of the surgical procedure will be collected: the number of curves, the curve magnitude, type of instrumentation required, the number of levels fused and the fluoroscopy time. The placement and type of wound drains and their .respective outputs will be noted. Preoperative and postoperative curve magnitude will be documented as well as instrumentation used to facilitate curve correction. The number of levels fused will be documented.
Hemoglobin and hematocrit levels will be noted at several intervals post operatively (24 hours, 48 hours and last result prior to discharge) and further transfusion requirement will be recorded. The length of Intensive Care Unit stay and the length of hospital stay will be noted. Regarding surgical procedure all patients will be operated on by the same surgical team, under standardized anesthesia, total intravenous anesthesia (TIVA), and postoperative analgesia. Data will be expressed as percentages or as a mean +/- SD. T-test analysis will be used for comparison for quantitative variables and a p value < 0.05 will be considered statistically significant
Eligibility| Ages Eligible for Study: | up to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
all patients undergoing surgical correction of scoliosis
Inclusion Criteria:
- all patients undergoing surgical correction of scoliosis
Contacts and Locations| Contact: Anuradha Patel, MD | 973 972-5254 | patelan@umdnj.edu |
| Contact: Catherine Schoenberg, BSN | 973 972 7477 | shoenbce@umdnj.edu |
| United States, New Jersey | |
| University Hospital | Recruiting |
| Newark, New Jersey, United States, 07101 | |
| Principal Investigator: Anuradha Patel, MD | |
| Sub-Investigator: Sanjeev Sabharwal, MD | |
| Principal Investigator: | Anuradha Patel, MD | UMDNJ/NJMS |
More Information
No publications provided
| Responsible Party: | Anesthesia, Department of Anesthesia/Investigator initiated, University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01490164 History of Changes |
| Other Study ID Numbers: | 0120090203 |
| Study First Received: | December 8, 2011 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013