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

NCT01251042 | Completed Results

• 1 other identifier: YA-DRA-0006
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in Plasma Free Hemoglobin (p-Hb) Concentration

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

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

Secondary Outcomes (12)

• Plasma Free Hemoglobin (p-Hb) Concentration

  At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)

• Hemoglobin Concentration

  At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)

• Potassium Concentration

  At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)

• Creatinine Concentration

  At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)

• Interleukin-1-alpha (IL-1-α) Concentration

  At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)

Study Arms (2)

Sangvia and retransfusion

EXPERIMENTAL

Device: Sangvia

Sangvia and no retransfusion

SHAM COMPARATOR

Device: Sangvia

Interventions

Sangvia DEVICE

The Sangvia® Blood Salvage System used to collect blood intra-operatively.

Sangvia and no retransfusion; Sangvia and retransfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

Clinical Trial Unit, Glostrup Hospital, University of Copenhagen

Glostrup Municipality, Denmark

Location

Results Point of Contact

• Title: Emma Tällberg, Clinical Research Manager
• Organization: Wellspect HealthCare

+46313764000

Study Officials

• Michael Rud Lassen, MD

  Glostrup Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: December 1, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 11, 2021
• Results First Posted: April 24, 2013

Record last verified: 2013-04

Locations

DK (1)