Anemia, Spine Surgery
Conditions
Keywords
Anemia, Tissue oxygenation, Spine surgery
Brief summary
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
Interventions
OTHERAllowed drop in hemoglobin to level between 4,5-5,6 mmol/L
Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L
OTHERAllowed drop in hemoglobin to level between 5,6-6,5 mmol/L
Transfusion with red blood cells to hemoglobin level between 5,6-6,5 mmol/L
Sponsors
TrygFonden, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Patients undergoing spine surgery * Be legally competent * Read and understand Danish
Exclusion criteria
* Present malignant disease * Previously apoplexia cerebri * Known heart disease with functionality equivalent to NYHA II or CCS II or worse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in subcutaneous oxygen tension from incision. | Every fifteen minutes throughout surgery | The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in the ST-segment of the ECG | Every fifteen minutes throughout surgery | — |
| Oxygenation of the brain | Every fifteen minutes throughout surgery | — |
| The concentration of lactate in plasma | Every half an hour throughout surgery | — |
| Muscular saturation of the deltoid muscle | Every fifteen minutes throughout surgery | The change in muscular saturation from incision until the time when most patientes are still undergoing surgery. Furthermore the lowest measured and the last measured muscular saturation is also evaluated. |
| The change in subcutaneous oxygen tension from incision. | Every fifteen minutes throughout surgery | The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery. |
Countries
Denmark
Outcome results
None listed