- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674906
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes (HECICS) (HECICS)
Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Genk, Limburg, Belgium, 3600
- Ziekenhuis Oost-Limburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HECICS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Intra Operative Bleeding, Blood Salvage
-
Baxter Healthcare CorporationBaxter Innovations GmbHCompletedIntra-operative BleedingCzech Republic, Germany, Hungary, Poland
-
Ain Shams UniversityCompleted
-
Erzincan UniversityUnknownIntra-operative Anesthesia
-
Erzincan UniversityUnknownIntra-operative Anesthesia
-
Catholic University of the Sacred HeartCompleted
-
Western Galilee Hospital-NahariyaCompletedPost Operative Complications | Intra-operative ComplicationsIsrael
-
Erzincan UniversityUnknownIntra-operative Anesthesia and Analgesia Effects
-
Washington University School of MedicineThe Foundation for Barnes-Jewish HospitalCompletedExplicit Recall of Intra-operative EventsUnited States
-
Washington University School of MedicineUniversity of Manitoba; University of Chicago; University of Michigan; American... and other collaboratorsCompletedExplicit Recall of Intra-Operative EventsUnited States, Canada
-
Meir Medical CenterNot yet recruiting
Clinical Trials on ACD-A
-
Peking University People's HospitalUnknown
-
Vasorum LtdCompletedCoronary Artery Disease | Cardiac DiseaseUnited States, Germany, Ireland
-
Advanced Circulatory SystemsNational Heart, Lung, and Blood Institute (NHLBI)TerminatedHeart Arrest | Cardiac Arrest | Cardiopulmonary Resuscitation | Death, Sudden, CardiacUnited States
-
Deraya UniversityMinia UniversityCompleted
-
Yonsei UniversityCompletedPatients Who Needs Sedation After Head & Neck SurgeryKorea, Republic of
-
Advanced Circulatory SystemsNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
THERAPIM PTY LTDNovotech (Australia) Pty LimitedTerminatedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Carcinoma | High Grade Serious or Endometrioid Carcinoma of the Ovary, Fallopian Tube, or Primary Peritoneal CancerAustralia
-
Johnson & Johnson Vision Care, Inc.CompletedCorneal Infiltrative Events | Corneal InflammationUnited States
-
Johnson & Johnson Vision Care, Inc.Completed