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


N/A
18 Years
N/A
Not Enrolling
Both
Spinal Surgery

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Difference in Plasma Free Hemoglobin (p-Hb) Concentration

Outcome Description:

Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery

Outcome Time Frame:

At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)

Safety Issue:

Yes

Principal Investigator

Michael Rud Lassen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Glostrup Hospital, University of Copenhagen

Authority:

Denmark: Ethics Committee

Study ID:

YA-DRA-0006

NCT ID:

NCT01251042

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Spinal Surgery

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