NCT02674906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

January 24, 2016

Last Update Submit

March 28, 2018

Conditions

Intra Operative Bleeding, Blood Salvage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC:

    maximum 3 hours post-operatively

Study Arms (2)

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

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.

Drug: Heparin

Interventions

ACD-ADRUG

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

Also known as: Anticoagulant Citrate Dextrose Solution--Formula A
citrate
HeparinDRUG

use of heparin as anticoagulant after blood salvage during cardiac surgery

Also known as: heparin sodium
heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cardiac revascularization surgery patients: subgroup analysis for
  • on pump coronary artery bypass grafting (CABG)
  • off pump CABG (OPCABG)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 37031168DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Intensivist

Study Record Dates

First Submitted

January 24, 2016

First Posted

February 5, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

BE(1)