Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery

NCT02112409 | Completed DMC

• 1 other identifier: MEC 201312-0621
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; scoliosis corrective surgery; autologous blood transfusion; cell salvage; acute normovolemic hemodilution; hemoglobin level

Outcome Measures

Primary Outcomes (1)

• 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.

  at 0 hour and 24 hour post-operation

Secondary Outcomes (1)

• Perioperative requirement of allogenic blood transfusion

  one week post-operation

Study Arms (2)

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.

Procedure: cell salvage technique; Procedure: acute normovolemic hemodilution

cell salvage

ACTIVE COMPARATOR

cell salvage technique throughout scoliosis corrective surgery

Procedure: cell salvage technique

Interventions

cell salvage technique PROCEDURE

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

Also known as: intraoperative blood salvage using cell saver

cell salvage; cell salvage and hemodilution technique

acute normovolemic hemodilution PROCEDURE

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

Also known as: intraoperative hemodilution technique

cell salvage and hemodilution technique

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Study Officials

• M Shahnaz Hasan, MBBS, MAnaes

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 14, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

MY (1)