Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02674906
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS)
Sponsor:
Ziekenhuis Oost-Limburg
Organization:
Study Overview
Official Title:
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HECICS
Brief Summary:
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.
Detailed Description:
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:
* total antioxidant status (TAS)
* Total thiols in proteins (TTP)
* oxidized LDL (oxLDL)
* Pro-inflammatory markers: interleukins (IL), IL-6, IL-8, myeloperoxidase (MPO)
* Anti-inflammatory marker: IL-10
The second primary outcome of this study is the difference in direct quality of the washed, salvaged red blood cells (RBC):
* Blood smear: evaluation by light microscopy
* Osmotic fragility
* Haemoglobin and hematocrit
* Free haemoglobin
* Free iron
* Lactate
* pH Confounding factors (CPB duration, contact time of anticoagulant with saved blood, time since first washing cycle in case of multiple washing cycles) will be controlled for.
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).
* C-reactive protein (CRP)
* TAS, TTP
* oxLDL
* IL-6, IL-8, IL-10
* MPO Markers for hemolysis in patient plasma preoperatively vs immediately pre- and post-transfusion of the salvaged RBC (indirect quality of the washed salvaged RBC).
* Free Hb
* Free iron, ferritin, transferrin
* Haptoglobin
* Hepcidin
* total antioxidant status (TAS)
* Total thiols in proteins (TTP)
* oxidized LDL (oxLDL)
* Pro-inflammatory markers: interleukins (IL), IL-6, IL-8, myeloperoxidase (MPO)
* Anti-inflammatory marker: IL-10
The second primary outcome of this study is the difference in direct quality of the washed, salvaged red blood cells (RBC):
* Blood smear: evaluation by light microscopy
* Osmotic fragility
* Haemoglobin and hematocrit
* Free haemoglobin
* Free iron
* Lactate
* pH Confounding factors (CPB duration, contact time of anticoagulant with saved blood, time since first washing cycle in case of multiple washing cycles) will be controlled for.
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).
* C-reactive protein (CRP)
* TAS, TTP
* oxLDL
* IL-6, IL-8, IL-10
* MPO Markers for hemolysis in patient plasma preoperatively vs immediately pre- and post-transfusion of the salvaged RBC (indirect quality of the washed salvaged RBC).
* Free Hb
* Free iron, ferritin, transferrin
* Haptoglobin
* Hepcidin
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: