Intra Operative Bleeding, Blood SalvageHECICSNCT02674906
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS)
A study testing ACD-A and Heparin in people with Intra Operative Bleeding, Blood Salvage, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Operative Bleeding, Blood Salvage
- What is being tested?
- ACD-A and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac revascularization surgery patients: subgroup analysis for
- on pump coronary artery bypass grafting (CABG)
- off pump CABG (OPCABG)
Who cannot join
- Urgent procedures
- Severe shock
- Active infection
- Inflammatory diseases
- Active neoplasia
- Immune suppressive drugs
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- ACD-A, Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACD-ADrug
Also called Anticoagulant Citrate Dextrose Solution--Formula A
use of ACD-A as anticoagulant after blood salvage during cardiac surgery
HeparinDrug
Also called heparin sodium
use of heparin as anticoagulant after blood salvage during cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| citrate | Active comparator | 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 Receives: Drug: ACD-A |
| heparin | Active comparator | 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. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: maximum 3 hours post-operatively
Secondary outcomes (1)
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
Measured: maximum 3 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra Operative Bleeding, Blood SalvageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willem Boer, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674906
- Sponsor's protocol ID
- HECICS
- Acronym
- HECICS
- Status last verified
- Mar 2018
- First submitted
- 24 Jan 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37031168
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).
- ClinicalTrials.gov ID
- NCT02674906
- Acronym / sponsor ID
- HECICS / HECICS
- Conditions
- Intra Operative Bleeding, Blood Salvage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citrate | Active comparator | Drug: ACD-AA 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 |
| heparin | Active comparator | Drug: HeparinA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective cardiac revascularization surgery patients: subgroup analysis for
- on pump coronary artery bypass grafting (CABG)
- off pump CABG (OPCABG)
Key exclusion criteria (10 listed)
- Urgent procedures
- Severe shock
- Active infection
- Inflammatory diseases
- Active neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACD-AAlso: Anticoagulant Citrate Dextrose Solution--Formula Ause of ACD-A as anticoagulant after blood salvage during cardiac surgery | Drug | citrate |
| HeparinAlso: heparin sodiumuse of heparin as anticoagulant after blood salvage during cardiac surgery | Drug | heparin |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 37031168Boer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACD-A and Heparin in people with Intra Operative Bleeding, Blood Salvage, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: maximum 3 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.