NCT04868214

Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies' PoC Coagulometer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sciema UG · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The Perosphere Technologies' PoC Coagulometer measures clotting times of fresh whole blood samples. Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly, the final step in the coagulation cascade. Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway, the Perosphere Technologies' PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes, including the Direct Oral Anticoagulants, DOACs (e.g. rivaroxaban, apixaban, and edoxaban), as well as the heparins (e.g. enoxaparin, a low molecular weight heparin, and unfractionated heparin). The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls, as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites.

Conditions

• Coagulation

Interventions

Type	Name	Description
DEVICE	coagulation measurements	peak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana.

Timeline

• Start date: 2021-04-20
• Primary completion: 2024-08-31
• Completion: 2024-10-30
• First posted: 2021-04-30
• Last updated: 2023-09-28

Locations

5 sites across 2 countries: United States, Germany