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Transfusion Requirements During Spinal Surgery for Severe Scoliosis

This study has been completed.
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey Identifier:
First received: December 8, 2011
Last updated: November 12, 2013
Last verified: November 2013
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.


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

Resource links provided by NLM:

Further study details as provided by Anesthesia, Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • transfusion requirements [ Time Frame: 0-72 hours ]
    number of blood transfusion subject required from surgical start time to 72 hours post op

Secondary Outcome Measures:
  • vertebral levels fused [ Time Frame: intraoperatively ]
    number of vertebral levels fused

Other Outcome Measures:
  • operative time [ Time Frame: time in OR ]
    surgical start and finish times

  • ICU stay [ Time Frame: days ]
    number of stays subject stays in ICU

  • hospital days [ Time Frame: days ]
    number of days until discharge

Enrollment: 50
Study Start Date: August 2009
Study Completion Date: November 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergoing surgical correction of scoliosis

Inclusion Criteria:

  • all patients undergoing surgical correction of scoliosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01490164

United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Principal Investigator: Anuradha Patel, MD UMDNJ/NJMS
  More Information

Responsible Party: Anesthesia, Department of Anesthesia/Investigator initiated, Rutgers, The State University of New Jersey Identifier: NCT01490164     History of Changes
Other Study ID Numbers: 0120090203
Study First Received: December 8, 2011
Last Updated: November 12, 2013

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on September 21, 2017