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Transfusion Requirements During Spinal Surgery for Severe Scoliosis

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ClinicalTrials.gov Identifier: NCT01490164
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey

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.

Condition or disease
Scoliosis

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


Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Prospective Study of Transfusion Requirements During Spinal Surgery for Severe Scoliosis
Study Start Date : August 2009
Primary Completion Date : July 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
scoliosis
young adults requiring surgical correction



Primary Outcome Measures :
  1. 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 :
  1. vertebral levels fused [ Time Frame: intraoperatively ]
    number of vertebral levels fused


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

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

  3. hospital days [ Time Frame: days ]
    number of days until discharge



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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
Criteria

Inclusion Criteria:

  • all patients undergoing surgical correction of scoliosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases