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

NCT ID: NCT01251042

Last Updated: 2021-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sangvia and retransfusion

Group Type: EXPERIMENTAL

Sangvia

Intervention Type: DEVICE

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

Sangvia and no retransfusion

Group Type: SHAM_COMPARATOR

Sangvia

Intervention Type: DEVICE

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

Interventions

Sangvia

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Rud Lassen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup Hospital, University of Copenhagen

Locations

Clinical Trial Unit, Glostrup Hospital, University of Copenhagen

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

YA-DRA-0006

Identifier Type: -

Identifier Source: org_study_id