Spinal SurgeryNCT01251042
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
A study testing Sangvia in people with Spinal Surgery, run by Wellspect HealthCare at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Surgery
- What is being tested?
- Sangvia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Trial Unit, Glostrup Hospital, University of Copenhagen
Glostrup Municipality
About this study
Official title: 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.
- Conditions
- Spinal Surgery
- Being tested
- Sangvia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SangviaDevice
The Sangvia® Blood Salvage System used to collect blood intra-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Sangvia and retransfusion | Experimental | Not described Receives: Device: Sangvia |
| Sangvia and no retransfusion | Sham comparator | Not described Receives: Device: Sangvia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Plasma Free Hemoglobin (p-Hb) Concentration
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
Measured: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)
Secondary outcomes (12)
Plasma Free Hemoglobin (p-Hb) Concentration
Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Hemoglobin Concentration
Systemic hemoglobin concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Potassium Concentration
Systemic potassium concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Creatinine Concentration
Systemic creatinine concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-1-alpha (IL-1-α) Concentration
Systemic IL-1-α concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-6 (IL-6) Concentration
Systemic IL-6 concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-8 (IL-8) Concentration
Systemic IL-8 concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interleukin-10 (IL-10) Concentration
Systemic IL-10 concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Systemic TNF-α concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interferon Gamma (IFN-γ) Concentration
Systemic IFN-γ concentration from screening until 96 hours after surgery.
Measured: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Mean Blood Loss Volume
Estimated blood loss during and after surgery.
Measured: After surgery (surgery takes place 1-7 days after screening)
Frequency of Allogenic Blood Transfusion
Measured: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Rud Lassen, MD, Principal investigator, Glostrup Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251042
- Sponsor's protocol ID
- YA-DRA-0006
- Status last verified
- Apr 2013
- First submitted
- 24 Sep 2010
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery
- ClinicalTrials.gov ID
- NCT01251042
- Acronym / sponsor ID
- YA-DRA-0006
- Conditions
- Spinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 24 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sangvia and retransfusion | Experimental | Device: Sangvia |
| Sangvia and no retransfusion | Sham comparator | Device: Sangvia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SangviaThe Sangvia® Blood Salvage System used to collect blood intra-operatively. | Device | Sangvia and no retransfusion, Sangvia and retransfusion |
Primary outcome
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)
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
12 secondary outcomes
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)
Potassium 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-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)
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)
Interleukin-10 (IL-10) 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-α) Concentration
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Interferon Gamma (IFN-γ) 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)
Frequency of Allogenic Blood Transfusion
Time frame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rud Lassen, MD principal investigator
Glostrup Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sangvia in people with Spinal Surgery, run by Wellspect HealthCare at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.