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Completed

NCT Number: NCT04976530

Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T)

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).

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Key information

Conditions

Hemorrhage, Surgical Blood Loss, Postoperative Blood Loss, Surgical Hemorrhage Hemorrhage Postoperative Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital, Winnipeg, Manitoba, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

DrugSorb-ATR system

Device

Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Other names: Sorbent hemoperfusion system

Sham Comparator

Device

Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Chest Tube Drainage, mITT Population

    Time frame: Through 24hrs post-operation

    Drainage volume from all chest and mediastinal tubes

  2. Chest Tube Drainage, i-CABG PP Population

    Time frame: Through 24hrs post-operation

    Drainage volume from all chest and mediastinal tubes

  3. Chest Tube Drainage, mITT Population

    Time frame: Through 12hrs post-operation

    Drainage volume from all chest and mediastinal tubes

  4. Chest Tube Drainage, i-CABG PP Population

    Time frame: Through 12hrs post-operation

    Drainage volume from all chest and mediastinal tubes

  5. 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

    Total PRBC transfusions (units) during hospitalization in the mITT population

  6. PRBC Transfusions, (Units) I-CABG PP Population

    Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

    Total PRBC transfusions (units) during hospitalization

  7. Platelet Transfusions (Units), mITT Population

    Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

    Total Platelet transfusions (units) during hospitalization

  8. Platelet Transfusions, (Units), I-CABG PP Population

    Time frame: From procedure start through to discharge from index hospitalization, on average 1-2 weeks

    Total Platelet transfusions (units) during hospitalization

Sponsors and collaborators

Lead sponsor

CytoSorbents, Inc

Industry

Registry information

Official study 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

Acronym: STAR-T

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 26, 2021
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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