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Trial record 12 of 39 for:    "Spinal Disease" | "Benzocaine"

Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery

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ClinicalTrials.gov Identifier: NCT02112409
Recruitment Status : Completed
First Posted : April 14, 2014
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
University of Malaya

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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Procedure: cell salvage technique Procedure: acute normovolemic hemodilution Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: intraoperative blood salvage using cell saver




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112409


Locations
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Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: M Shahnaz Hasan, MBBS, MAnaes University of Malaya

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02112409     History of Changes
Other Study ID Numbers: MEC 201312-0621
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by University of Malaya:
Adolescent idiopathic scoliosis
scoliosis corrective surgery
autologous blood transfusion
cell salvage
acute normovolemic hemodilution
hemoglobin level
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases