Adolescent Idiopathic ScoliosisNCT02112409
Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery
A study testing cell salvage technique and acute normovolemic hemodilution in people with Adolescent Idiopathic Scoliosis, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- cell salvage technique and acute normovolemic hemodilution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- cell salvage technique, acute normovolemic hemodilution
- Keywords
- Adolescent idiopathic scoliosis, scoliosis corrective surgery, autologous blood transfusion, cell salvage, acute normovolemic hemodilution, hemoglobin level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell salvage techniqueProcedure or surgery
Also called intraoperative blood salvage using cell saver
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
acute normovolemic hemodilutionProcedure or surgery
Also called intraoperative hemodilution technique
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
| Study group | Role | What they receive |
|---|---|---|
| cell salvage and hemodilution technique | Experimental | cell salvage technique throughout scoliosis corrective surgery; Acute normovolemic hemodilution technique commenced after induction of anaesthesia and prior the starting of surgery. Receives: Procedure: cell salvage technique; Procedure: acute normovolemic hemodilution |
| cell salvage | Active comparator | cell salvage technique throughout scoliosis corrective surgery Receives: Procedure: cell salvage technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 0 hour and 24 hour post-operation
Secondary outcomes (1)
Perioperative requirement of allogenic blood transfusion
participants (patients) will be followed for the duration of hospital stay, an expected average of one week.
Measured: one week post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Shahnaz Hasan, MBBS, MAnaes, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112409
- Sponsor's protocol ID
- MEC 201312-0621
- Status last verified
- Jun 2015
- First submitted
- 5 Apr 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Blood Transfusion Technique in Idiopathic Scoliosis Surgery - a Comparison Between Intraoperative Cell Salvage With Hemodilution Techniques Versus Cell Salvage Technique Alone
- ClinicalTrials.gov ID
- NCT02112409
- Acronym / sponsor ID
- MEC 201312-0621
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, scoliosis corrective surgery, autologous blood transfusion, cell salvage, acute normovolemic hemodilution, hemoglobin level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell salvage and hemodilution technique | Experimental | Procedure: cell salvage technique, Procedure: acute normovolemic hemodilutioncell salvage technique throughout scoliosis corrective surgery; Acute normovolemic hemodilution technique commenced after induction of anaesthesia and prior the starting of surgery. |
| cell salvage | Active comparator | Procedure: cell salvage techniquecell salvage technique throughout scoliosis corrective surgery |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell salvage techniqueAlso: intraoperative blood salvage using cell saverblood 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 | Procedure or surgery | cell salvage, cell salvage and hemodilution technique |
| acute normovolemic hemodilutionAlso: intraoperative hemodilution techniqueRemoval 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 | Procedure or surgery | cell salvage and hemodilution technique |
Primary outcome
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.
1 secondary outcome
Perioperative requirement of allogenic blood transfusion
Time frame: one week post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M Shahnaz Hasan, MBBS, MAnaes principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cell salvage technique and acute normovolemic hemodilution in people with Adolescent Idiopathic Scoliosis, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pre-operative and post-operative hemoglobin level (time frame: at 0 hour and 24 hour post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.