Clinical trial NCT02674906: Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS)
Official title: Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra Operative Bleeding, Blood Salvage
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: Inclusion Criteria:

Elective cardiac revascularization surgery patients: subgroup analysis for

* on pump coronary artery bypass grafting (CABG)
* off pump CABG (OPCABG)

Exclusion Criteria:

* Urgent procedures
* Severe shock
* Active infection
* Inflammatory diseases
* Active neoplasia
* Immune suppressive drugs
* Active or recent renal replacement therapy (RRT)
* Anticoagulation or anti-aggregation therapy that hasn't been timely interrupted according to guidelines (12,13)
* Need for allogenous blood transfusion before completion of data collection
* Massive peroperative bleeding that cannot be safely managed while collecting study data

Primary outcomes:
measure: 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
timeFrame: maximum 3 hours post-operatively
Secondary outcomes:
measure: The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC:
timeFrame: maximum 3 hours post-operatively
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: