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

NCT ID: NCT02674906

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-06-30

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

Conditions

Intra Operative Bleeding, Blood Salvage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

citrate

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

Group Type: ACTIVE_COMPARATOR

ACD-A

Intervention Type: DRUG

use of ACD-A as anticoagulant after blood salvage during cardiac surgery

heparin

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.

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

use of heparin as anticoagulant after blood salvage during cardiac surgery

Interventions

ACD-A

use of ACD-A as anticoagulant after blood salvage during cardiac surgery

Intervention Type: DRUG

Heparin

use of heparin as anticoagulant after blood salvage during cardiac surgery

Intervention Type: DRUG

Other Intervention Names

Anticoagulant Citrate Dextrose Solution--Formula A; heparin sodium

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Willem Boer

Consultant Intensivist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 37031168 (View on PubMed)

Other Identifiers

HECICS

Identifier Type: -

Identifier Source: org_study_id