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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 November 2021
• Main ID: NCT01251042
• Date of registration: 24/09/2010
• Prospective Registration: Yes
• Primary sponsor: Wellspect HealthCare
• Public title: Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
• Scientific title: A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
• Date of first enrolment: October 2010
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01251042
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Michael Rud Lassen, MD
• Affiliation: Glostrup Hospital, University of Copenhagen

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Surgery

Intervention(s)

Device: Sangvia

Primary Outcome(s)

Difference in Plasma Free Hemoglobin (p-Hb) Concentration [Time Frame: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)]

Secondary Outcome(s)

Frequency of Allogenic Blood Transfusion [Time Frame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Plasma Free Hemoglobin (p-Hb) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Hemoglobin Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Creatinine Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Interleukin-10 (IL-10) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Interleukin-6 (IL-6) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Interleukin-8 (IL-8) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Tumor Necrosis Factor Alpha (TNF-a) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Mean Blood Loss Volume [Time Frame: After surgery (surgery takes place 1-7 days after screening)]

Interleukin-1-alpha (IL-1-a) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Interferon Gamma (IFN-?) Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Potassium Concentration [Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)]

Secondary ID(s)

YA-DRA-0006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01251042