- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01251042
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
November 10, 2021 updated by: Wellspect HealthCare
A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Glostrup, Denmark
- Clinical Trial Unit, Glostrup Hospital, University of Copenhagen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sangvia and retransfusion
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The Sangvia® Blood Salvage System used to collect blood intra-operatively.
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SHAM_COMPARATOR: Sangvia and no retransfusion
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The Sangvia® Blood Salvage System used to collect blood intra-operatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.
|
At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Hemoglobin Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic hemoglobin concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Potassium Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic potassium concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Creatinine Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic creatinine concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Interleukin-1-alpha (IL-1-α) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic IL-1-α concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Interleukin-6 (IL-6) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic IL-6 concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Interleukin-8 (IL-8) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic IL-8 concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Interleukin-10 (IL-10) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic IL-10 concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic TNF-α concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Interferon Gamma (IFN-γ) Concentration
Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Systemic IFN-γ concentration from screening until 96 hours after surgery.
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At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Mean Blood Loss Volume
Time Frame: After surgery (surgery takes place 1-7 days after screening)
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Estimated blood loss during and after surgery.
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After surgery (surgery takes place 1-7 days after screening)
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Frequency of Allogenic Blood Transfusion
Time Frame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Rud Lassen, MD, Glostrup Hospital, University of Copenhagen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
November 30, 2010
First Posted (ESTIMATE)
December 1, 2010
Study Record Updates
Last Update Posted (ACTUAL)
November 11, 2021
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
April 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- YA-DRA-0006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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