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The primary aim of this randomized controlled study is to determine whether the use Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim is to determine whether any differences in activation can be correlated to any differences in postoperative clinical outcome.
The first primary outcome of this study is the difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir, after correction for cardiopulmonary bypass (CPB) time up to the start of the first washing cycle and contact time of the anticoagulant (either ACD A or heparin) with the saved blood:
The second primary outcome of this study is the difference in direct quality of the washed, salvaged red blood cells (RBC):
Secondary outcome:
The difference in concentration of the same pro/anti-inflammatory and oxidative stress markers in patient plasma preoperatively vs immediately before and after transfusion of cell saver blood (2 to 3 hours after transfusion and before extubation or transfusion of allogenous blood).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| citrate | Active Comparator | A quantity of 20 ml ACD-A per 100 ml of collected blood is used to prevent coagulation in the cell savage process. Pre-prepared ACD-A solutions is available (composition of ACD-A solution used: 22.0 g sodium citrate dehydrate, 24.5 g glucose monohydrate, 8.0 g citric acid monohydrate per 1000 ml of water |
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| heparin | Active Comparator | A heparinised saline solution of 25,000 IU of heparin per 1 litre of intravenous normal saline (0.9% NaCl) solution is used with a dosage of 20 ml of solution per 100 ml of collected blood. This type of solution is not commercially available and is made locally. This solution is used in the cell salvage process to prevent coagulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACD-A | Drug | use of ACD-A as anticoagulant after blood salvage during cardiac surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir | measurement of: TAS: total antioxidant status TTP: total thiols in proteins oxLDL: oxidized LDL Pro-inflammatory markers: IL-6, IL-8, myeloperoxidase (MPO) Anti-inflammatory marker: IL-10 | maximum 3 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC: | The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC: Blood smear: evaluation by light microscopy Osmotic fragility Haemoglobin and hematocrit Free haemoglobin Free iron Lactate pH | maximum 3 hours post-operatively |
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Inclusion Criteria:
Elective cardiac revascularization surgery patients: subgroup analysis for
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37031168 | Derived | Boer W, van Tornout M, Brusseleers M, Strauven M, de Vooght P, Vander Laenen M, Hoste E, Jorens PG. The effects of differing anticoagulant regimes on blood quality after cell salvage in coronary artery bypass grafting (CABG): a pilot study. J Cardiothorac Surg. 2023 Apr 8;18(1):116. doi: 10.1186/s13019-023-02246-w. |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Heparin | Drug | use of heparin as anticoagulant after blood salvage during cardiac surgery |
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