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

March 28, 2018 updated by: Willem Boer, Ziekenhuis Oost-Limburg

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
use of ACD-A as anticoagulant after blood salvage during cardiac surgery
Other Names:
  • Anticoagulant Citrate Dextrose Solution--Formula A
Active Comparator: 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.
use of heparin as anticoagulant after blood salvage during cardiac surgery
Other Names:
  • heparin sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: maximum 3 hours post-operatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC:
Time Frame: maximum 3 hours post-operatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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