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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) Concentration

Hemoglobin 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

Page last updated: August 20, 2015

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