NCT05093504

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: CytoSorbents, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	Sham comparator	Sham comparator in similar position to the investigational device, but NOT integrated into the cardiopulmonary bypass (CPB) circuit
DEVICE	DrugSorb-ATR system	Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit

Timeline

• Start date: 2021-12-27
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2021-10-26
• Last updated: 2025-05-04
• Results posted: 2025-05-04

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study