Spinal Surgery
Conditions
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.
Interventions
DEVICESangvia
The Sangvia® Blood Salvage System used to collect blood intra-operatively.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Plasma Free Hemoglobin (p-Hb) Concentration | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic hemoglobin concentration from screening until 96 hours after surgery. |
| Potassium Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic potassium concentration from screening until 96 hours after surgery. |
| Creatinine Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic creatinine concentration from screening until 96 hours after surgery. |
| Interleukin-1-alpha (IL-1-α) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic IL-1-α concentration from screening until 96 hours after surgery. |
| Interleukin-6 (IL-6) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic IL-6 concentration from screening until 96 hours after surgery. |
| Plasma Free Hemoglobin (p-Hb) Concentration | 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. |
| Interleukin-10 (IL-10) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic IL-10 concentration from screening until 96 hours after surgery. |
| Tumor Necrosis Factor Alpha (TNF-α) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic TNF-α concentration from screening until 96 hours after surgery. |
| Interferon Gamma (IFN-γ) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic IFN-γ concentration from screening until 96 hours after surgery. |
| Mean Blood Loss Volume | After surgery (surgery takes place 1-7 days after screening) | Estimated blood loss during and after surgery. |
| Frequency of Allogenic Blood Transfusion | Up until 96 hours after surgery (surgery takes place 1-7 days after screening) | — |
| Interleukin-8 (IL-8) Concentration | At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) | Systemic IL-8 concentration from screening until 96 hours after surgery. |
Countries
Denmark
Participant flow
Pre-assignment details
51 subjects were enrolled but 2 subjects were never randomized and have thus not been included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Sangvia and Retransfusion Blood collected and retransfused with Sangvia. | 26 |
| Sangvia and no Retransfusion Blood collected with Sangvia but discarded, i.e. not retransfused. | 23 |
| Total | 49 |
Baseline characteristics
| Characteristic | Sangvia and Retransfusion | Sangvia and no Retransfusion | Total |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 14 |
| Region of Enrollment Denmark | 26 participants | 23 participants | 49 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 26 | 17 / 23 |
| serious Total, serious adverse events | 3 / 26 | 4 / 23 |
Outcome results
Primary
Difference in Plasma Free Hemoglobin (p-Hb) Concentration
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
Time frame: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sangvia and Retransfusion | Difference in Plasma Free Hemoglobin (p-Hb) Concentration | 0.1 g/l | Standard Deviation 0.2 |
| Sangvia and no Retransfusion | Difference in Plasma Free Hemoglobin (p-Hb) Concentration | 0.0 g/l | Standard Deviation 0.1 |
p-value: 0.6294Wilcoxon (Mann-Whitney)
Secondary
Creatinine Concentration
Systemic creatinine concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Creatinine Concentration | Screening | 64 μmol/l | Standard Deviation 13 |
| Sangvia and Retransfusion | Creatinine Concentration | At Randomization (0 hrs) | 65 μmol/l | Standard Deviation 12 |
| Sangvia and Retransfusion | Creatinine Concentration | End of transfusion | 68 μmol/l | Standard Deviation 13 |
| Sangvia and Retransfusion | Creatinine Concentration | 3 hours | 66 μmol/l | Standard Deviation 12 |
| Sangvia and Retransfusion | Creatinine Concentration | 6 hours | 62 μmol/l | Standard Deviation 12 |
| Sangvia and Retransfusion | Creatinine Concentration | 24 hours | 61 μmol/l | Standard Deviation 12 |
| Sangvia and Retransfusion | Creatinine Concentration | 48 hours | 62 μmol/l | Standard Deviation 12 |
| Sangvia and Retransfusion | Creatinine Concentration | 96 hours | 59 μmol/l | Standard Deviation 12 |
| Sangvia and no Retransfusion | Creatinine Concentration | 96 hours | 64 μmol/l | Standard Deviation 14 |
| Sangvia and no Retransfusion | Creatinine Concentration | Screening | 70 μmol/l | Standard Deviation 15 |
| Sangvia and no Retransfusion | Creatinine Concentration | 6 hours | 64 μmol/l | Standard Deviation 12 |
| Sangvia and no Retransfusion | Creatinine Concentration | At Randomization (0 hrs) | 69 μmol/l | Standard Deviation 16 |
| Sangvia and no Retransfusion | Creatinine Concentration | 48 hours | 67 μmol/l | Standard Deviation 16 |
| Sangvia and no Retransfusion | Creatinine Concentration | End of transfusion | NA μmol/l | — |
| Sangvia and no Retransfusion | Creatinine Concentration | 24 hours | 66 μmol/l | Standard Deviation 17 |
| Sangvia and no Retransfusion | Creatinine Concentration | 3 hours | 72 μmol/l | Standard Deviation 16 |
Secondary
Frequency of Allogenic Blood Transfusion
Time frame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sangvia and Retransfusion | Frequency of Allogenic Blood Transfusion | 8 percentage of participants |
| Sangvia and no Retransfusion | Frequency of Allogenic Blood Transfusion | 22 percentage of participants |
Secondary
Hemoglobin Concentration
Systemic hemoglobin concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Hemoglobin Concentration | Screening | 14.2 g/dl | Standard Deviation 1.1 |
| Sangvia and Retransfusion | Hemoglobin Concentration | At Randomization (0 hrs) | 11.8 g/dl | Standard Deviation 1.1 |
| Sangvia and Retransfusion | Hemoglobin Concentration | End of transfusion | 12.5 g/dl | Standard Deviation 1.1 |
| Sangvia and Retransfusion | Hemoglobin Concentration | 3 hours | 12.5 g/dl | Standard Deviation 1.1 |
| Sangvia and Retransfusion | Hemoglobin Concentration | 6 hours | 12.4 g/dl | Standard Deviation 1.2 |
| Sangvia and Retransfusion | Hemoglobin Concentration | 24 hours | 11.6 g/dl | Standard Deviation 1.2 |
| Sangvia and Retransfusion | Hemoglobin Concentration | 48 hours | 11.4 g/dl | Standard Deviation 1 |
| Sangvia and Retransfusion | Hemoglobin Concentration | 96 hours | 11.2 g/dl | Standard Deviation 1.3 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | 96 hours | 10.9 g/dl | Standard Deviation 1.5 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | Screening | 13.8 g/dl | Standard Deviation 1.3 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | 6 hours | 11.5 g/dl | Standard Deviation 1.2 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | At Randomization (0 hrs) | 11.1 g/dl | Standard Deviation 1.5 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | 48 hours | 10.8 g/dl | Standard Deviation 1.7 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | End of transfusion | NA g/dl | — |
| Sangvia and no Retransfusion | Hemoglobin Concentration | 24 hours | 10.8 g/dl | Standard Deviation 1.2 |
| Sangvia and no Retransfusion | Hemoglobin Concentration | 3 hours | 11.6 g/dl | Standard Deviation 1.3 |
Secondary
Interferon Gamma (IFN-γ) Concentration
Systemic IFN-γ concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | End of transfusion | 4.50 pg/ml | Standard Deviation 4.24 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | 24 hours | 3.94 pg/ml | Standard Deviation 3.12 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | At Randomization (0 hrs) | 3.89 pg/ml | Standard Deviation 5.35 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | 48 hours | 4.00 pg/ml | Standard Deviation 3.49 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | 3 hours | 4.54 pg/ml | Standard Deviation 5.15 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | 96 hours | 4.25 pg/ml | Standard Deviation 3.6 |
| Sangvia and Retransfusion | Interferon Gamma (IFN-γ) Concentration | Screening | 7.45 pg/ml | Standard Deviation 14.17 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | 96 hours | 7.14 pg/ml | Standard Deviation 7.18 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | Screening | 8.61 pg/ml | Standard Deviation 18.9 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | At Randomization (0 hrs) | 7.37 pg/ml | Standard Deviation 15.85 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | 3 hours | 8.31 pg/ml | Standard Deviation 19.15 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | 24 hours | 7.98 pg/ml | Standard Deviation 16.78 |
| Sangvia and no Retransfusion | Interferon Gamma (IFN-γ) Concentration | 48 hours | 5.94 pg/ml | Standard Deviation 7.29 |
Secondary
Interleukin-10 (IL-10) Concentration
Systemic IL-10 concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | End of transfusion | 70.65 pg/ml | Standard Deviation 100.88 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | 24 hours | 5.29 pg/ml | Standard Deviation 4.26 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | At Randomization (0 hrs) | 4.59 pg/ml | Standard Deviation 3.44 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | 48 hours | 3.54 pg/ml | Standard Deviation 1.48 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | 3 hours | 50.60 pg/ml | Standard Deviation 81.04 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | 96 hours | 2.15 pg/ml | Standard Deviation 1.34 |
| Sangvia and Retransfusion | Interleukin-10 (IL-10) Concentration | Screening | 2.25 pg/ml | Standard Deviation 2.72 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | 96 hours | 2.67 pg/ml | Standard Deviation 1.12 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | Screening | 2.07 pg/ml | Standard Deviation 1.19 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | At Randomization (0 hrs) | 7.99 pg/ml | Standard Deviation 9.88 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | 3 hours | 18.36 pg/ml | Standard Deviation 18.11 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | 24 hours | 4.27 pg/ml | Standard Deviation 2.49 |
| Sangvia and no Retransfusion | Interleukin-10 (IL-10) Concentration | 48 hours | 4.96 pg/ml | Standard Deviation 3.23 |
Secondary
Interleukin-1-alpha (IL-1-α) Concentration
Systemic IL-1-α concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | At Randomization (0 hrs) | 13.66 pg/ml | Standard Deviation 18.37 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 3 hours | 14.04 pg/ml | Standard Deviation 17.17 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | Screening | 18.36 pg/ml | Standard Deviation 24.14 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 48 hours | 12.63 pg/ml | Standard Deviation 15.06 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | End of transfusion | 14.97 pg/ml | Standard Deviation 16.21 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 96 hours | 13.44 pg/ml | Standard Deviation 16.15 |
| Sangvia and Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 24 hours | 12.45 pg/ml | Standard Deviation 14.26 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 96 hours | 17.41 pg/ml | Standard Deviation 14.1 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 24 hours | 22.16 pg/ml | Standard Deviation 34.34 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | Screening | 23.44 pg/ml | Standard Deviation 36.3 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | At Randomization (0 hrs) | 22.39 pg/ml | Standard Deviation 37.35 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 3 hours | 26.69 pg/ml | Standard Deviation 51.07 |
| Sangvia and no Retransfusion | Interleukin-1-alpha (IL-1-α) Concentration | 48 hours | 15.74 pg/ml | Standard Deviation 14.47 |
Secondary
Interleukin-6 (IL-6) Concentration
Systemic IL-6 concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | End of transfusion | 37.30 pg/ml | Standard Deviation 46 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | 24 hours | 116.65 pg/ml | Standard Deviation 171.29 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | At Randomization (0 hrs) | 7.27 pg/ml | Standard Deviation 6.12 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | 48 hours | 118.05 pg/ml | Standard Deviation 163.19 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | 3 hours | 58.29 pg/ml | Standard Deviation 87.34 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | 96 hours | 29.14 pg/ml | Standard Deviation 24 |
| Sangvia and Retransfusion | Interleukin-6 (IL-6) Concentration | Screening | 8.35 pg/ml | Standard Deviation 9.38 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | 96 hours | 32.51 pg/ml | Standard Deviation 19.15 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | Screening | 8.94 pg/ml | Standard Deviation 10.45 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | At Randomization (0 hrs) | 9.71 pg/ml | Standard Deviation 9.71 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | 3 hours | 64.20 pg/ml | Standard Deviation 93.69 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | 24 hours | 118.89 pg/ml | Standard Deviation 192.73 |
| Sangvia and no Retransfusion | Interleukin-6 (IL-6) Concentration | 48 hours | 163.73 pg/ml | Standard Deviation 188.09 |
Secondary
Interleukin-8 (IL-8) Concentration
Systemic IL-8 concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | End of transfusion | 4.32 pg/ml | Standard Deviation 6.41 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | 24 hours | 2.05 pg/ml | Standard Deviation 1.53 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | At Randomization (0 hrs) | 2.34 pg/ml | Standard Deviation 2.67 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | 48 hours | 2.57 pg/ml | Standard Deviation 2.27 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | 3 hours | 5.17 pg/ml | Standard Deviation 9.14 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | 96 hours | 2.48 pg/ml | Standard Deviation 1.96 |
| Sangvia and Retransfusion | Interleukin-8 (IL-8) Concentration | Screening | 1.35 pg/ml | Standard Deviation 1.07 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | 96 hours | 2.70 pg/ml | Standard Deviation 1.61 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | Screening | 1.35 pg/ml | Standard Deviation 0.76 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | At Randomization (0 hrs) | 2.01 pg/ml | Standard Deviation 2.54 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | 3 hours | 2.91 pg/ml | Standard Deviation 2.79 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | 24 hours | 3.13 pg/ml | Standard Deviation 2.33 |
| Sangvia and no Retransfusion | Interleukin-8 (IL-8) Concentration | 48 hours | 3.77 pg/ml | Standard Deviation 2.88 |
Secondary
Mean Blood Loss Volume
Estimated blood loss during and after surgery.
Time frame: After surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Mean Blood Loss Volume | Intra-operative | 623 ml | Full Range 444 |
| Sangvia and Retransfusion | Mean Blood Loss Volume | Post-operative | 392 ml | — |
| Sangvia and Retransfusion | Mean Blood Loss Volume | Total | 1015 ml | — |
| Sangvia and no Retransfusion | Mean Blood Loss Volume | Intra-operative | 742 ml | — |
| Sangvia and no Retransfusion | Mean Blood Loss Volume | Post-operative | 420 ml | — |
| Sangvia and no Retransfusion | Mean Blood Loss Volume | Total | 1162 ml | — |
Secondary
Plasma Free Hemoglobin (p-Hb) Concentration
Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | Screening | 0.2 g/l | Standard Deviation 0.2 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | At Randomization (0 hrs) | 0.2 g/l | Standard Deviation 0.2 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | End of transfusion | 1.2 g/l | Standard Deviation 0.7 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 3 hours | 0.9 g/l | Standard Deviation 0.7 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 6 hours | 0.5 g/l | Standard Deviation 0.1 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 24 hours | 0.1 g/l | Standard Deviation 0.1 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 48 hours | 0.1 g/l | Standard Deviation 0.1 |
| Sangvia and Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 96 hours | 0.1 g/l | Standard Deviation 0.2 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 96 hours | 01. g/l | Standard Deviation 0.1 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | Screening | 0.1 g/l | Standard Deviation 0.1 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 6 hours | 0.0 g/l | Standard Deviation 0.1 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | At Randomization (0 hrs) | 0.2 g/l | Standard Deviation 0.2 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 48 hours | 0.1 g/l | Standard Deviation 0.3 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | End of transfusion | NA g/l | — |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 24 hours | 0.1 g/l | Standard Deviation 0.1 |
| Sangvia and no Retransfusion | Plasma Free Hemoglobin (p-Hb) Concentration | 3 hours | 0.1 g/l | Standard Deviation 0.1 |
Secondary
Potassium Concentration
Systemic potassium concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Potassium Concentration | Screening | 4.2 mmol/l | Standard Deviation 0.3 |
| Sangvia and Retransfusion | Potassium Concentration | At Randomization (0 hrs) | 4.2 mmol/l | Standard Deviation 0.4 |
| Sangvia and Retransfusion | Potassium Concentration | End of transfusion | 4.1 mmol/l | Standard Deviation 0.4 |
| Sangvia and Retransfusion | Potassium Concentration | 3 hours | 4.0 mmol/l | Standard Deviation 0.4 |
| Sangvia and Retransfusion | Potassium Concentration | 6 hours | 4.2 mmol/l | Standard Deviation 0.5 |
| Sangvia and Retransfusion | Potassium Concentration | 24 hours | 3.9 mmol/l | Standard Deviation 0.3 |
| Sangvia and Retransfusion | Potassium Concentration | 48 hours | 4.0 mmol/l | Standard Deviation 0.6 |
| Sangvia and Retransfusion | Potassium Concentration | 96 hours | 4.0 mmol/l | Standard Deviation 0.4 |
| Sangvia and no Retransfusion | Potassium Concentration | 96 hours | 4.0 mmol/l | Standard Deviation 0.5 |
| Sangvia and no Retransfusion | Potassium Concentration | Screening | 4.4 mmol/l | Standard Deviation 0.4 |
| Sangvia and no Retransfusion | Potassium Concentration | 6 hours | 4.3 mmol/l | Standard Deviation 0.4 |
| Sangvia and no Retransfusion | Potassium Concentration | At Randomization (0 hrs) | 4.1 mmol/l | Standard Deviation 0.7 |
| Sangvia and no Retransfusion | Potassium Concentration | 48 hours | 4.0 mmol/l | Standard Deviation 0.5 |
| Sangvia and no Retransfusion | Potassium Concentration | End of transfusion | NA mmol/l | — |
| Sangvia and no Retransfusion | Potassium Concentration | 24 hours | 4.0 mmol/l | Standard Deviation 0.4 |
| Sangvia and no Retransfusion | Potassium Concentration | 3 hours | 4.3 mmol/l | Standard Deviation 0.4 |
Secondary
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Systemic TNF-α concentration from screening until 96 hours after surgery.
Time frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)
Population: All subjects randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | End of transfusion | 17.43 pg/ml | Standard Deviation 28.41 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 24 hours | 11.55 pg/ml | Standard Deviation 23.6 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | At Randomization (0 hrs) | 16.14 pg/ml | Standard Deviation 30.51 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 48 hours | 9.84 pg/ml | Standard Deviation 24.05 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 3 hours | 16.23 pg/ml | Standard Deviation 28.25 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 96 hours | 10.37 pg/ml | Standard Deviation 20.56 |
| Sangvia and Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | Screening | 25.40 pg/ml | Standard Deviation 52.7 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 96 hours | 5.49 pg/ml | Standard Deviation 7.71 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | Screening | 15.42 pg/ml | Standard Deviation 34.15 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | At Randomization (0 hrs) | 13.87 pg/ml | Standard Deviation 28.37 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | End of transfusion | NA pg/ml | — |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 3 hours | 14.02 pg/ml | Standard Deviation 28.16 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 24 hours | 7.86 pg/ml | Standard Deviation 17.32 |
| Sangvia and no Retransfusion | Tumor Necrosis Factor Alpha (TNF-α) Concentration | 48 hours | 7.69 pg/ml | Standard Deviation 15.98 |