Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery

June 3, 2015 updated by: University of Malaya

Autologous Blood Transfusion Technique in Idiopathic Scoliosis Surgery - a Comparison Between Intraoperative Cell Salvage With Hemodilution Techniques Versus Cell Salvage Technique Alone

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cell salvage and hemodilution technique
cell salvage technique throughout scoliosis corrective surgery; Acute normovolemic hemodilution technique commenced after induction of anaesthesia and prior the starting of surgery.
Procedure: cell salvage technique
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
Other Names:
  • intraoperative blood salvage using cell saver
Procedure: acute normovolemic hemodilution
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
Other Names:
  • intraoperative hemodilution technique
Active Comparator: cell salvage
cell salvage technique throughout scoliosis corrective surgery
Procedure: cell salvage technique
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
Other Names:
  • intraoperative blood salvage using cell saver

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in pre-operative and post-operative hemoglobin level
Time Frame: at 0 hour and 24 hour post-operation
Laboratory testing for hemoglobin level will be carry out at 0 hour and 24 hour post-operation.
at 0 hour and 24 hour post-operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perioperative requirement of allogenic blood transfusion
Time Frame: one week post-operation
participants (patients) will be followed for the duration of hospital stay, an expected average of one week.
one week post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: M Shahnaz Hasan, MBBS, MAnaes, University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEC 201312-0621

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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