Transfusion Requirements During Spinal Surgery for Severe Scoliosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01490164
First received: December 8, 2011
Last updated: November 12, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • vertebral levels fused [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
    number of vertebral levels fused


Other Outcome Measures:
  • 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


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)
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
Study Population

all patients undergoing surgical correction of scoliosis

Criteria

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 ClinicalTrials.gov identifier: NCT01490164

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

No publications provided

Responsible Party: Anesthesia, Department of Anesthesia/Investigator initiated, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01490164     History of Changes
Other Study ID Numbers: 0120090203
Study First Received: December 8, 2011
Last Updated: November 12, 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 July 28, 2014