Transfusion Requirements During Spinal Surgery for Severe Scoliosis

An Observational Prospective Study of Transfusion Requirements During Spinal Surgery for Severe Scoliosis

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 Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing surgical correction of scoliosis

Description

Inclusion Criteria:

• all patients undergoing surgical correction of scoliosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
scoliosis; young adults requiring surgical correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transfusion requirements	number of blood transfusion subject required from surgical start time to 72 hours post op	0-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vertebral levels fused	number of vertebral levels fused	intraoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	surgical start and finish times	time in OR
ICU stay	number of stays subject stays in ICU	days
hospital days	number of days until discharge	days

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Anuradha Patel, MD, UMDNJ/NJMS

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (Estimate): December 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 0120090203