Clinical trial NCT01251042: Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
Official title: A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Surgery
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Difference in Plasma Free Hemoglobin (p-Hb) Concentration
timeFrame: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)
Secondary outcomes:
measure: Plasma Free Hemoglobin (p-Hb) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Hemoglobin Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Potassium Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Creatinine Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Interleukin-1-alpha (IL-1-α) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Interleukin-6 (IL-6) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Interleukin-8 (IL-8) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Interleukin-10 (IL-10) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Tumor Necrosis Factor Alpha (TNF-α) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Interferon Gamma (IFN-γ) Concentration
timeFrame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
measure: Mean Blood Loss Volume
timeFrame: After surgery (surgery takes place 1-7 days after screening)
measure: Frequency of Allogenic Blood Transfusion
timeFrame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Clinical Trial Unit, Glostrup Hospital, University of Copenhagen
Study officials:
affiliation: Glostrup Hospital, University of Copenhagen
name: Michael Rud Lassen, MD
role: PRINCIPAL_INVESTIGATOR
References: