Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood

A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery

The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood has been collected, the subject will be randomized to either be retransfused with the blood collected (investigational group) or not (control group). The primary objective for this study is to investigate the blood quality and isolate the systemic effects in intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the primary outcome variable based on previous experience and literature and is considered as the major safety concern for the study subjects.

Study Overview

• Status: Completed
• Conditions: Spinal Surgery
• Intervention / Treatment: Device: Sangvia

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark
    • Clinical Trial Unit, Glostrup Hospital, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of informed consent.
• Male and female subjects aged 18 years and over subjected to spinal surgery with an approximate expected bleeding of 800-1500 ml.
• Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

Exclusion Criteria:

• Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site).
• Previous enrolment or randomisation of treatment in the present study.
• Participation in another clinical study, that may interfere with the present study.
• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech.
• Haemophilia.
• Hyperkalemia (i.e. values above the normal reference values at study site).
• Symptoms of impaired renal function including creatinine clearance levels (using the Cockcroft-Gault formula) <30 ml/min.
• Malignancy in the area of the operative site.
• Current or expected use of cytotoxic drugs.
• Symptoms of systemic infection or local infection in the operation field.
• Pregnancy.
• Sickle cell anaemia and/or pre-operative Hb concentration <11 g/dl (6,8 mmol/l).
• Use of recombinant erythropoietin (EPO) or fibrin sealant.
• Use of other autologous blood transfusion than with the Sangvia® system (e.g. CellSaver and pre-donation) or other blood saving techniques (e.g. normovolemic hemodilution).
• Hypotensive anesthesia.
• Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sangvia and retransfusion	Device: Sangvia; The Sangvia® Blood Salvage System used to collect blood intra-operatively.
SHAM_COMPARATOR: Sangvia and no retransfusion	Device: Sangvia; The Sangvia® Blood Salvage System used to collect blood intra-operatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Plasma Free Hemoglobin (p-Hb) Concentration	Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery	At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Free Hemoglobin (p-Hb) Concentration	Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Hemoglobin Concentration	Systemic hemoglobin concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Potassium Concentration	Systemic potassium concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Creatinine Concentration	Systemic creatinine concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-1-alpha (IL-1-α) Concentration	Systemic IL-1-α concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-6 (IL-6) Concentration	Systemic IL-6 concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-8 (IL-8) Concentration	Systemic IL-8 concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-10 (IL-10) Concentration	Systemic IL-10 concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Tumor Necrosis Factor Alpha (TNF-α) Concentration	Systemic TNF-α concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interferon Gamma (IFN-γ) Concentration	Systemic IFN-γ concentration from screening until 96 hours after surgery.	At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Mean Blood Loss Volume	Estimated blood loss during and after surgery.	After surgery (surgery takes place 1-7 days after screening)
Frequency of Allogenic Blood Transfusion		Up until 96 hours after surgery (surgery takes place 1-7 days after screening)

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Michael Rud Lassen, MD, Glostrup Hospital, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: September 24, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (ESTIMATE): December 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: YA-DRA-0006