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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sangvia and retransfusion | Experimental |
| |
| Sangvia and no retransfusion | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sangvia | Device | The Sangvia® Blood Salvage System used to collect blood intra-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Free Hemoglobin (p-Hb) Concentration | 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) |
| Hemoglobin Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Rud Lassen, MD | Glostrup Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Unit, Glostrup Hospital, University of Copenhagen | Glostrup Municipality | Denmark |
51 subjects were enrolled but 2 subjects were never randomized and have thus not been included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sangvia and Retransfusion | Blood collected and retransfused with Sangvia. |
| FG001 | Sangvia and no Retransfusion | Blood collected with Sangvia but discarded, i.e. not retransfused. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sangvia and Retransfusion | Blood collected and retransfused with Sangvia. |
| BG001 | Sangvia and no Retransfusion | Blood collected with Sangvia but discarded, i.e. not retransfused. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Plasma Free Hemoglobin (p-Hb) Concentration | Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | g/l | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sangvia and Retransfusion | Blood collected and retransfused with Sangvia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychosis | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Tällberg, Clinical Research Manager | Wellspect HealthCare | +46313764000 |
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Systemic hemoglobin 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) |
| Potassium Concentration | Systemic potassium 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) |
| Creatinine Concentration | Systemic creatinine 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) |
| Interleukin-1-alpha (IL-1-α) Concentration | Systemic IL-1-α 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) |
| Interleukin-6 (IL-6) Concentration | Systemic IL-6 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) |
| Interleukin-8 (IL-8) Concentration | Systemic IL-8 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) |
| Interleukin-10 (IL-10) Concentration | Systemic IL-10 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) |
| Tumor Necrosis Factor Alpha (TNF-α) Concentration | Systemic TNF-α 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) |
| Interferon Gamma (IFN-γ) Concentration | Systemic IFN-γ 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) |
| Mean Blood Loss Volume | Estimated blood loss during and after surgery. | After surgery (surgery takes place 1-7 days after screening) |
| Frequency of Allogenic Blood Transfusion | Up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Hemoglobin Concentration | Systemic hemoglobin concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | g/dl | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Potassium Concentration | Systemic potassium concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | mmol/l | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Creatinine Concentration | Systemic creatinine concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | μmol/l | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Primary | Difference in Plasma Free Hemoglobin (p-Hb) Concentration | Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery | All subjects randomized. | Posted | Mean | Standard Deviation | g/l | At screening and 24 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
|
| Secondary | Interleukin-1-alpha (IL-1-α) Concentration | Systemic IL-1-α concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Interleukin-6 (IL-6) Concentration | Systemic IL-6 concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Interleukin-8 (IL-8) Concentration | Systemic IL-8 concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Interleukin-10 (IL-10) Concentration | Systemic IL-10 concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Tumor Necrosis Factor Alpha (TNF-α) Concentration | Systemic TNF-α concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Interferon Gamma (IFN-γ) Concentration | Systemic IFN-γ concentration from screening until 96 hours after surgery. | All subjects randomized. | Posted | Mean | Standard Deviation | pg/ml | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Mean Blood Loss Volume | Estimated blood loss during and after surgery. | All subjects randomized. | Posted | Mean | Full Range | ml | After surgery (surgery takes place 1-7 days after screening) |
|
|
|
| Secondary | Frequency of Allogenic Blood Transfusion | All subjects randomized. | Posted | Number | percentage of participants | Up until 96 hours after surgery (surgery takes place 1-7 days after screening) |
|
|
|
| 3 |
| 26 |
| 23 |
| 26 |
| EG001 | Sangvia and no Retransfusion | Blood collected with Sangvia but discarded, i.e. not retransfused. | 4 | 23 | 17 | 23 |
| Bronchial spasm | Respiratory, thoracic and mediastinal disorders |
|
| Nerve contusion | Nervous system disorders |
|
| Leg pain | Musculoskeletal and connective tissue disorders |
|
| Wound infection | Infections and infestations |
|
| Wound oozing | Infections and infestations |
|
| Campylobacter infection | Infections and infestations |
|
| Dizziness | Cardiac disorders |
|
| Leg pain | Musculoskeletal and connective tissue disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Hematuria | Renal and urinary disorders |
|
| Decreased hemoglobin | Investigations |
|
| Fever | General disorders |
|
| Syncope | Cardiac disorders |
|
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| End of transfusion |
|
| 3 hours |
|
| 6 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 6 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 6 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| End of transfusion |
|
| 3 hours |
|
| 24 hours |
|
| 48 hours |
|
| 96 hours |
|
| Total |
|