Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
cell salvage technique
acute normovolemic hemodilution
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis, scoliosis corrective surgery, autologous blood transfusion, cell salvage, acute normovolemic hemodilution, hemoglobin level
Eligibility Criteria
Inclusion Criteria:
- Elective single stage posterior spinal fusion for scoliosis corrective surgery
- Diagnosis of idiopathic scoliosis
- Age >10 and <25
- ASA I or II
- Preoperative Hemoglobin > 10 g/dL
- Preoperative Platelet > 150,000/L
- Clinically fit for surgery
- Written informed consent
Exclusion Criteria:
- Patient's refusal of homologous blood
- Hematological disorder rendering either transfusion technique inappropriate
- Patients who received anticoagulants and antiplatelets perioperatively
- Severe cardiac disease (Aortic stenosis or cardiac ejection fraction <40%; Myocardial infarction in the previous 6 Months; Myocardial ischaemia on resting Electrocardiogram)
- Severe pulmonary disease (FEV1 50% predicted, PaO2 9 kpa on air)
- Preoperative creatinine >200 mmol/L
- AST >100 IU/L
Sites / Locations
- University Malaya Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cell salvage and hemodilution technique
cell salvage
Arm Description
cell salvage technique throughout scoliosis corrective surgery; Acute normovolemic hemodilution technique commenced after induction of anaesthesia and prior the starting of surgery.
cell salvage technique throughout scoliosis corrective surgery
Outcomes
Primary Outcome Measures
Difference in pre-operative and post-operative hemoglobin level
Laboratory testing for hemoglobin level will be carry out at 0 hour and 24 hour post-operation.
Secondary Outcome Measures
Perioperative requirement of allogenic blood transfusion
participants (patients) will be followed for the duration of hospital stay, an expected average of one week.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02112409
Brief Title
Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery
Official Title
Autologous Blood Transfusion Technique in Idiopathic Scoliosis Surgery - a Comparison Between Intraoperative Cell Salvage With Hemodilution Techniques Versus Cell Salvage Technique Alone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgical correction of scoliosis with instrumentation carries significant blood loss and needs for blood transfusion with its inherent risk and cost. In recent years, there is an increased interest in utilizing autologous blood as part of perioperative blood conservation strategy.
The foremost mechanical methods of perioperative conservation of red blood cells including intraoperative cell salvage (ICS) and acute normovolemic hemodilution (ANH). They should be considered in all cases where significant blood loss (>1000 ml) or >20% estimated blood volume is expected, in patients with multiple antibodies or rare blood types and those who refuse allogenic blood products.
Literature search has revealed that both cell salvage method and ANH utilized in elective surgeries are capable of minimizing allogenic blood transfusion respectively. Surgeries which are of significant relevance are aortic surgery, cardiac surgery and arthroplasty orthopaedic surgery. Combining the above two techniques such as in ATIS trial 2002 also shows that it is safe and significantly reduced allogenic blood requirements in aortic surgery. However till date, there is still lack of strong evidence that autologous blood transfusion technique is beneficial for scoliosis surgery in reducing allogenic blood transfusion.
Hypothesis:
The investigators hypothesize that the addition of ANH to ICS would confer additional benefit than using cell saver alone. By combining cell saver with hemodilution technique, the difference between pre-operative and post-operative Hemoglobin level will be smaller than using cell saver technique alone, hence minimizing the variation in perioperative Hemoglobin level - a predictor of allogenic blood transfusion.
Detailed Description
Patients who meet the inclusion criteria are enrolled in the study. They are assigned to 2 arms of study group using concealed allocation method. A computerized random-number generator will be used to formulate an allocation schedule. Group A will receive cell salvage and acute normovolemic hemodilution during operation; Group B will only receive cell salvage as sole autologous transfusion strategy.
Members of the research team should attend all operations and record all data. Anaesthetic technique including drugs usage, equipments and monitoring devices are standardized as per protocol. Intraoperative fluid management is recorded in details.
All patients enrolled in the study (group A and B) underwent cell saver technique during surgery using Cell Saver® 5+ autologous blood recovery system-Haemonetics devices. All patients allocated in group A also received additional acute normovolemic hemodilution (ANH) after induction of anaesthesia. As a standardization measure, before starting skin incision, 500ml blood will be collected from the radial artery to a standard blood collection bag and stored as CPD blood at ambient temperature. Simultaneously, 500ml Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride) will be infused through a peripheral vein.
All autologous blood will be re-infused back to patient at surgery completion or within 6 hours of withdrawal. Autologous blood will be given to patient during surgery at any point if there are 30% or more body blood volume loss.
Allogenic blood will be administered when the intraoperative hemoglobin concentration fell below 8g/dl despite completion of autologous blood transfusion or when autologous blood not available; adequate volume correction by mean of collected autologous blood and crystalloid fluid administration, or when presence of ischemic electrocardiogram changes (2mV ST segment elevation or depression on 3 leads monitoring); persistent hypotension or tachycardia >20% from baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis, scoliosis corrective surgery, autologous blood transfusion, cell salvage, acute normovolemic hemodilution, hemoglobin level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cell salvage and hemodilution technique
Arm Type
Experimental
Arm Description
cell salvage technique throughout scoliosis corrective surgery; Acute normovolemic hemodilution technique commenced after induction of anaesthesia and prior the starting of surgery.
Arm Title
cell salvage
Arm Type
Active Comparator
Arm Description
cell salvage technique throughout scoliosis corrective surgery
Intervention Type
Procedure
Intervention Name(s)
cell salvage technique
Other Intervention Name(s)
intraoperative blood salvage using cell saver
Intervention Description
blood from the surgical field is collected, anti-coagulated, filtered, centrifuged, washed and re-suspended in saline to produce autologous blood with a resultant haematocrit of 50-80% for transfusion back to the patient using specific cell saver device
Intervention Type
Procedure
Intervention Name(s)
acute normovolemic hemodilution
Other Intervention Name(s)
intraoperative hemodilution technique
Intervention Description
Removal of 500ml whole blood from the patient after induction of anesthesia, with restoration of blood volume with acellular fluid using equivolume of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven) to maintain isovolemia
Primary Outcome Measure Information:
Title
Difference in pre-operative and post-operative hemoglobin level
Description
Laboratory testing for hemoglobin level will be carry out at 0 hour and 24 hour post-operation.
Time Frame
at 0 hour and 24 hour post-operation
Secondary Outcome Measure Information:
Title
Perioperative requirement of allogenic blood transfusion
Description
participants (patients) will be followed for the duration of hospital stay, an expected average of one week.
Time Frame
one week post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective single stage posterior spinal fusion for scoliosis corrective surgery
Diagnosis of idiopathic scoliosis
Age >10 and <25
ASA I or II
Preoperative Hemoglobin > 10 g/dL
Preoperative Platelet > 150,000/L
Clinically fit for surgery
Written informed consent
Exclusion Criteria:
Patient's refusal of homologous blood
Hematological disorder rendering either transfusion technique inappropriate
Patients who received anticoagulants and antiplatelets perioperatively
Severe cardiac disease (Aortic stenosis or cardiac ejection fraction <40%; Myocardial infarction in the previous 6 Months; Myocardial ischaemia on resting Electrocardiogram)
Severe pulmonary disease (FEV1 50% predicted, PaO2 9 kpa on air)
Preoperative creatinine >200 mmol/L
AST >100 IU/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Shahnaz Hasan, MBBS, MAnaes
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
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Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery
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