Hemorrhage, SurgicalSTAR-TNCT04976530
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)
A study testing DrugSorb-ATR system in people with Hemorrhage, Surgical and Blood Loss, Surgical, run by CytoSorbents, Inc at 29 sites in 2 countries.
Trial summary
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative
- What is being tested?
- DrugSorb-ATR system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 31 Aug 2021to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female 18 years of age or older, with documented full, written informed consent
- Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Who cannot join
- CT surgery occurring 3 days or greater following ticagrelor discontinuation
- Heart-lung transplant procedures
- Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
- Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis [HITT], perioperative platelet count < 50,000u/L, hemophilia, and international normalized ratio [INR] >1.5)
- Prohibited concomitant antithrombotic medications as defined in the study protocol
- Acute sickle cell crisis
Show all 14Show fewer
- Known allergy to device components
- Active (untreated) systemic infection
- History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
- Women with positive pregnancy test during current admission or who are breast-feeding
- Life expectancy <30 days
- Inability to comply with requirements of the study protocol
- Treatment with investigational drug or device within 30 days of current surgery
- Previous enrollment in this trial
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States22 sites
Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, 30308
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont Medical Center
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29425
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Lutheran Medical Group
Fort Wayne, Indiana, 46804
University of Iowa
Iowa City, Iowa, 52242
University of Mississippi
Jackson, Mississippi, 39216
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Virtua Health
Marlton, New Jersey, 08053
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Yale New Haven Hospital
New Haven, Connecticut, 06510
New York University Langone Health
New York, New York, 10016
Baylor Scott & White The Heart Hospital Plano
Plano, Texas, 75093
Rhode Island Hospital
Providence, Rhode Island, 02903
VCU Medical Center
Richmond, Virginia, 23219
Carilion Clinic
Roanoke, Virginia, 24014
University of California, Davis Medical Center
Sacramento, California, 95817
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Canada7 sites
Hamilton General Hospital, Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M5B 1W8
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Safe, Timely Antithrombotic Removal-Ticagrelor (STAR-T): Double-blind Randomized Study of Reduction in Bleeding by Ticagrelor Removal Via Intraop Use of DrugSorb-Antithrombotic Removal (ATR) in Cardiac Surgery Patients <2 Days of Drug Stop
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
Read the detailed description
Antithrombotic agents such as ticagrelor can increase the risk of surgical bleeding in patients undergoing CT surgery if there is not adequate washout time of the drug. Patients who require urgent surgery may not be able to wait for the recommended washout time (up to 7 days). The intraoperative use of the DrugSorb-ATR device to remove active ticagrelor may help reduce the risk of postoperative surgical bleeding in these patients.
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Being tested
- DrugSorb-ATR system, Sham comparator
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrugSorb-ATR systemDevice
Also called Sorbent hemoperfusion system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Sham comparatorDevice
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Standard of care with Sham set-up Receives: Device: Sham comparator |
| DrugSorb-ATR Intervention | Experimental | Standard of care + DrugSorb-ATR system Receives: Device: DrugSorb-ATR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population
Incidence of periop bleeding, primary effectiveness composite endpoint, mITT population. Primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins > 1.0 favors the treatment arm. 95% confidence interval (CI) and p-value are calculated accordingly. The win ratio is 1.07 (95% CI 0.72, 1.58), p=0.748.
Measured: Through the first 48hrs post-operation
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population
Incidence of periop bleeding, primary effectiveness composite endpoint, i--CABG population. The primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in the Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.33 (95% confidence interval 0.86, 2.04) p-value 0.202.
Measured: Through the first 48hrs post operation
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers given below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.17 (95% confidence interval 0.79, 1.73) p value 0.451.
Measured: Through the first 48 hours post-operation
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.59 (95% confidence interval 1.02, 2.46) p-value 0.041.
Measured: Through the first 48hrs post-operation
Secondary outcomes (8)
Chest Tube Drainage, mITT Population
Drainage volume from all chest and mediastinal tubes
Measured: Through 24hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Drainage volume from all chest and mediastinal tubes
Measured: Through 24hrs post-operation
Chest Tube Drainage, mITT Population
Drainage volume from all chest and mediastinal tubes
Measured: Through 12hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Drainage volume from all chest and mediastinal tubes
Measured: Through 12hrs post-operation
Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population
Total PRBC transfusions (units) during hospitalization in the mITT population
Measured: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions, (Units) I-CABG PP Population
Total PRBC transfusions (units) during hospitalization
Measured: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units), mITT Population
Total Platelet transfusions (units) during hospitalization
Measured: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions, (Units), I-CABG PP Population
Total Platelet transfusions (units) during hospitalization
Measured: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start31 Aug 2021
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, SurgicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Mack, MD, Principal investigator, Baylor Scott & White The Heart HospitalC. M Gibson, MD, Principal investigator, Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical SchoolRichard Whitlock, MD, Principal investigator, Hamilton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976530
- Sponsor's protocol ID
- 2021-01
- Acronym
- STAR-T
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2021
- Last updated
- 26 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mould DR, Sweeney KR, Prats J, Fan W, Schneider DJ, Storey RF, Deliargyris EN. Pharmacokinetic Modeling of Ticagrelor and Ticagrelor Active Metabolite Removal by the DrugSorb-ATR Device in a Randomized Controlled Study of Patients Undergoing Cardiac Surgery. J Cardiovasc Pharmacol. 2026 Feb 1;87(2):105-113. doi: 10.1097/FJC.0000000000001779.
PubMed 41642317Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.
PubMed 35657375
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe, Timely Antithrombotic Removal-Ticagrelor (STAR-T): Double-blind Randomized Study of Reduction in Bleeding by Ticagrelor Removal Via Intraop Use of DrugSorb-Antithrombotic Removal (ATR) in Cardiac Surgery Patients <2 Days of Drug Stop
- ClinicalTrials.gov ID
- NCT04976530
- Acronym / sponsor ID
- STAR-T / 2021-01
- Conditions
- Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative, Hemorrhage Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-Antithrombotic Removal (ATR) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
Detailed description
Antithrombotic agents such as ticagrelor can increase the risk of surgical bleeding in patients undergoing CT surgery if there is not adequate washout time of the drug. Patients who require urgent surgery may not be able to wait for the recommended washout time (up to 7 days). The intraoperative use of the DrugSorb-ATR device to remove active ticagrelor may help reduce the risk of postoperative surgical bleeding in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Sham comparatorStandard of care with Sham set-up |
| DrugSorb-ATR Intervention | Experimental | Device: DrugSorb-ATR systemStandard of care + DrugSorb-ATR system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female 18 years of age or older, with documented full, written informed consent
- Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)
Key exclusion criteria (14 listed)
- CT surgery occurring 3 days or greater following ticagrelor discontinuation
- Heart-lung transplant procedures
- Procedures for implant or revision of left ventricular assist device (LVAD) or right ventricular assist device (RVAD)
- Pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis [HITT], perioperative platelet count < 50,000u/L, hemophilia, and international normalized ratio [INR] >1.5)
- Prohibited concomitant antithrombotic medications as defined in the study protocol
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 |
|---|---|---|
| DrugSorb-ATR systemAlso: Sorbent hemoperfusion systemSorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit | Device | DrugSorb-ATR Intervention |
| Sham comparatorSham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit | Device | Control |
Primary outcome
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population
Time frame: Through the first 48hrs post-operation
Incidence of periop bleeding, primary effectiveness composite endpoint, mITT population. Primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins > 1.0 favors the treatment arm. 95% confidence interval (CI) and p-value are calculated accordingly. The win ratio is 1.07 (95% CI 0.72, 1.58), p=0.748.
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Isolated Coronary Artery Bypass Grafting (I-CABG) Per Protocol (PP) Population
Time frame: Through the first 48hrs post operation
Incidence of periop bleeding, primary effectiveness composite endpoint, i--CABG population. The primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) moderate, severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >2 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in the Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.33 (95% confidence interval 0.86, 2.04) p-value 0.202.
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT Population
Time frame: Through the first 48 hours post-operation
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, mITT population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers given below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.17 (95% confidence interval 0.79, 1.73) p value 0.451.
Incidence of Perioperative (Periop) Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG Per Protocol (PP) Population
Time frame: Through the first 48hrs post-operation
Incidence of Periop Bleeding, Supplemental Primary Effectiveness Composite Endpoint, I-CABG population. The supplementary primary effectiveness endpoint was a composite of (ranked) 1) fatal periop bleeding; 2) severe, or massive bleeding events based on the universal definition for periop bleeding (UDPB) >3 classification; and 3) 24 hour chest tube drainage (CTD) volume; evaluated by an unmatched win ratio method. Using the hierarchical order of the components of each composite endpoint every patient in the Sham arm is compared with every patient in the DrugSorb-ATR arm to make Ns x Nd pairs. The numbers below are the number of 'winners' for two treatments; a 'win' is given for the better outcome in the pair, eg, less bleeding. The win ratio is the total number of winners in DrugSorb-ATR arm divided by the total number of winners in Sham arm. A ratio of wins >1.0 favors the treatment arm. The win ratio was 1.59 (95% confidence interval 1.02, 2.46) p-value 0.041.
8 secondary outcomes
Chest Tube Drainage, mITT Population
Time frame: Through 24hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Time frame: Through 24hrs post-operation
Chest Tube Drainage, mITT Population
Time frame: Through 12hrs post-operation
Chest Tube Drainage, i-CABG PP Population
Time frame: Through 12hrs post-operation
Packed Red Blood Cell (PRBC) Transfusions (Units), mITT Population
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions, (Units) I-CABG PP Population
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units), mITT Population
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions, (Units), I-CABG PP Population
Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41642317Mould DR, Sweeney KR, Prats J, Fan W, Schneider DJ, Storey RF, Deliargyris EN. Pharmacokinetic Modeling of Ticagrelor and Ticagrelor Active Metabolite Removal by the DrugSorb-ATR Device in a Randomized Controlled Study of Patients Undergoing Cardiac Surgery. J Cardiovasc Pharmacol. 2026 Feb 1;87(2):105-113. doi: 10.1097/FJC.0000000000001779.
- Derived from this study: PubMed 35657375Tripathi R, Morales J, Lee V, Gibson CM, Mack MJ, Schneider DJ, Douketis J, Sellke FW, Ohman ME, Thourani VH, Storey RF, Deliargyris EN. Antithrombotic drug removal from whole blood using Haemoadsorption with a porous polymer bead sorbent. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):847-856. doi: 10.1093/ehjcvp/pvac036.
- Individual participant dataSharing planned: No
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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.
Michael J Mack, MD principal investigator
Baylor Scott & White The Heart Hospital
C. M Gibson, MD principal investigator
Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
Richard Whitlock, MD principal investigator
Hamilton General Hospital
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DrugSorb-ATR system in people with Hemorrhage, Surgical and Blood Loss, Surgical, run by CytoSorbents, Inc at 29 sites in 2 countries.
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 2 inclusion and 14 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population (time frame: Through the first 48hrs post-operation). The study lists 4 primary outcomes in all. 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 NCT04976530, which also lists 2 linked publications.
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 26 Oct 2026.