Hemorrhage, SurgicalSTAR-DNCT05093504

Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)

A study testing DrugSorb-ATR system in people with Hemorrhage, Surgical and Hemorrhage Postoperative, run by CytoSorbents, Inc at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical
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: 9 participants
Where: 27 sitesUnited States
Study dates: 27 Dec 2021to 29 Jan 2024
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 age 18 years or older, with documented full, written informed consent
Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)

Who cannot join

>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
Patients on low dose apixaban or rivaroxaban for prophylactic indications
Heart-lung transplant procedures
Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
Any of the below conditions that pose a known risk for increased bleeding
Heparin induced thrombocytopenia

Show all 19Show fewer

Preoperative platelet count <50,000u/L
Hemophilia
International normalized ratio (INR) greater than or equal to 1.8
Prohibited concomitant antithrombotic medications as defined in the study protocol
Acute sickle cell crisis
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

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, 30308
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
University of Maryland Medical Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Bethesda North Hospital, TriHealth, Inc
Cincinnati, Ohio, 45242
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
University of Colorado
Denver, Colorado, 80045
Henry Ford Health System
Detroit, Michigan, 48202
Lutheran Medical Group
Fort Wayne, Indiana, 46804
University of Mississippi
Jackson, Mississippi, 39216
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Bryan Medical Center
Lincoln, Nebraska, 68506
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Virtua Health
Marlton, New Jersey, 08053
Baptist Hospital of Miami and its Miami Cardiac and Vascular Institute
Miami, Florida, 33176
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Yale University
New Haven, Connecticut, 06510
NYU Langone Medical Center
New York, New York, 10016
Advent Health
Orlando, Florida, 32803
Baylor Scott & White The Heart Hospital
Plano, Texas, 75093
Rhode Island Hospital
Providence, Rhode Island, 02903
VCU Medical Center
Richmond, Virginia, 23219
University of California, Davis Medical Center
Sacramento, California, 95817
University of South Florida
Tampa, Florida, 33606

Other trials in United States

About this study

Official title: Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients

Read the detailed description

The Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants (DOACs) Apixaban \& Rivaroxaban (STAR-D) study is a prospective, multicenter, double-blind, randomized study that evaluated the DrugSorb™-Antithrombotic Removal (ATR) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. The objectives were

To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.
To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ[DOAC]) with the intraoperative use of DrugSorb-ATR.
To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.

Conditions: Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
Being tested: Sham comparator, DrugSorb-ATR system
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.

Sham comparatorDevice
Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
DrugSorb-ATR systemDevice
Also called Sorbent hemoperfusion system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Study groups in NCT05093504
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 Bleeding
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint
Measured: Through the first 48 hours post-operation

Secondary outcomes (9)

Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
Percent change in blood apixaban or rivaroxaban levels from pre coronary bypass (CPB), that is, start of device use to 30 min post CPB
Measured: Through 30 minutes post-CPB
Chest Tube Drainage
Drainage volume from all chest and mediastinal tubes
Measured: Through 24 hours post-operation
Platelet Transfusions (Volume)
Total platelet transfusions (mL) during hospitalization
Measured: Through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units)
Total platelet transfusions (units) during hospitalization
Measured: Through to discharge from index hospitalization, on average 1-2 weeks
Packed Red Blood Cell (PRBC) Transfusions (Volume)
Total PRBC transfusions (mL) during hospitalization
Measured: Through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions (Units)
Total PRBC transfusions (units) during hospitalization
Measured: Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events
Perioperative bleeding events classified according to the Universal Definition of Perioperative Bleeding, and analyzed by class (Class 0, 1, 2, 3, 4)
Measured: Through the first day post-operation
Surgical Re-exploration for Bleeding
All surgical re-explorations for excessive bleeding, as adjudicated by an independent Clinical Events Committee
Measured: Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Fatal Perioperative Bleeding
Deaths directly attributable to procedure-related bleeding.
Measured: 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.

27 Dec 202129 Jan 2024

First posted26 Oct 2021
Study start27 Dec 2021
Primary completion29 Jan 2024
Study completion29 Jan 2024

Why it stopped: Sponsor's decision for business reasons.

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 (1)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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05093504
Sponsor's protocol ID: 2021-02
Acronym: STAR-D
Status last verified: Apr 2025
First submitted: 1 Oct 2021
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Tripathi 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safe & Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D): Prospective, Multicenter, Double-blind, Randomized Study of Apixaban & Rivaroxaban Removal to Reduce Risk of Serious Bleeding in Urgent Cardiac Surgery Patients
ClinicalTrials.gov ID: NCT05093504
Acronym / sponsor ID: STAR-D / 2021-02
Conditions: Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision for business reasons.
Enrolment: 9 participants (actual)
Lead sponsor: CytoSorbents, IncIndustry (pharma, biotech, devices)
Study start: 27 Dec 2021 (actual)
Primary completion: 29 Jan 2024 (actual)
Study completion: 29 Jan 2024 (actual)
First posted: 26 Oct 2021 (actual)
Results: Posted 4 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of DrugSorb-ATR in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose.
To demonstrate reductions in apixaban or rivaroxaban blood levels (Δ[DOAC]) with the intraoperative use of DrugSorb-ATR.
To establish the safety of the intraoperative use of DrugSorb-ATR in the intended population.

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 age 18 years or older, with documented full, written informed consent
Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within 36 hours from last dose of either apixaban or rivaroxaban (*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism)

Key exclusion criteria (19 listed)

>48hrs between last apixaban or rivaroxaban dose and start of CT surgery
Patients on low dose apixaban or rivaroxaban for prophylactic indications
Heart-lung transplant procedures
Procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device [LVAD] or right ventricular assist device [RVAD])
Any of the below conditions that pose a known risk for increased bleeding

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
Sham comparatorSham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit	Device	Control
DrugSorb-ATR systemAlso: Sorbent hemoperfusion systemSorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit	Device	DrugSorb-ATR Intervention

Primary outcome

Incidence of Perioperative Bleeding
Time frame: Through the first 48 hours post-operation
Incidence of clinically significant perioperative bleeding events, as evaluated by a ranked composite endpoint

9 secondary outcomes

Direct Oral Anticoagulant (DOAC) Drug Removal: Apixaban and Rivaroxaban
Time frame: Through 30 minutes post-CPB
Chest Tube Drainage
Time frame: Through 24 hours post-operation
Platelet Transfusions (Volume)
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Platelet Transfusions (Units)
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Packed Red Blood Cell (PRBC) Transfusions (Volume)
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
PRBC Transfusions (Units)
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Moderate, Severe, and Massive Perioperative Bleeding Events
Time frame: Through the first day post-operation
Surgical Re-exploration for Bleeding
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks
Incidence of Fatal Perioperative Bleeding
Time frame: Through to discharge from index hospitalization, on average 1-2 weeks

Results and safety

Results posted to the registry on 4 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	5	5
DrugSorb-ATR Intervention	4	3

Primary outcome: Incidence of Perioperative Bleeding

Time frame: Through the first 48 hours post-operation

Population analysed: The trial was terminated before the outcome measure data were cleaned and adjudicated. All bleeding outcomes data were to be adjudicated by a Clinical Events Committee, which was not convened because the trial was terminated. Therefore, no bleeding outcomes were available.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the study duration, that is, within 30 days post-operation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	1 of 5 (20%)	2 of 5 (40%)	0 of 5
DrugSorb-ATR Intervention	2 of 4 (50%)	2 of 4 (50%)	1 of 4

Limitations and caveats (from the sponsor): The study was terminated early for business reasons, due to low enrollment. Outcome data was not cleaned, nor adjudicated. The only outcome available to analyze was the percent change in drug levels for both direct oral anticoagulants or DOACs rivaroxaban and apixaban together--there were not enough subjects to analyze DOAC levels separately.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

Related trials for Hemorrhage, Surgical

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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

27 sites in 1 country: 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 Hemorrhage Postoperative, run by CytoSorbents, Inc at 27 sites in United States.

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 19 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: stopped early, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. 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 4 May 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 Bleeding (time frame: Through the first 48 hours post-operation). 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 NCT05093504, 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 4 May 2025.