Transfusion Requirements During Spinal Surgery for Severe Scoliosis

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490164
• Other study ID #: 0120090203
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: November 12, 2013
• Start date: August 2009
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

• all patients undergoing surgical correction of scoliosis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operative time	surgical start and finish times	time in OR	No
Other	ICU stay	number of stays subject stays in ICU	days	No
Other	hospital days	number of days until discharge	days	No
Primary	transfusion requirements	number of blood transfusion subject required from surgical start time to 72 hours post op	0-72 hours	No
Secondary	vertebral levels fused	number of vertebral levels fused	intraoperatively	No