Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
Information source: Wellspect HealthCare
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Surgery
Intervention: Sangvia (Device)
Phase: N/A
Status: Completed
Sponsored by: Wellspect HealthCare Official(s) and/or principal investigator(s): Michael Rud Lassen, MD, Principal Investigator, Affiliation: Glostrup Hospital, University of Copenhagen
Summary
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.
Clinical Details
Official title: A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Difference in Plasma Free Hemoglobin (p-Hb) Concentration
Secondary outcome: Plasma Free Hemoglobin (p-Hb) ConcentrationHemoglobin Concentration Potassium Concentration Creatinine Concentration Interleukin-1-alpha (IL-1-α) Concentration Interleukin-6 (IL-6) Concentration Interleukin-8 (IL-8) Concentration Interleukin-10 (IL-10) Concentration Tumor Necrosis Factor Alpha (TNF-α) Concentration Interferon Gamma (IFN-γ) Concentration Mean Blood Loss Volume Frequency of Allogenic Blood Transfusion
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Clinical Trial Unit, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark
Additional Information
Starting date: October 2010
Last updated: April 29, 2013
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