Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS)

Intra Operative Bleeding, Blood Salvage Clinical Trial

— HECICS  

Official title:

Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674906
• Other study ID #: HECICS
• Status: Completed
• Phase: N/A
• First received: January 24, 2016
• Last updated: March 28, 2018
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2018
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Inflammation
• Intra Operative Bleeding, Blood Salvage

Intervention

Drug:
• ACD-A
use of ACD-A as anticoagulant after blood salvage during cardiac surgery
• Heparin
use of heparin as anticoagulant after blood salvage during cardiac surgery

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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