Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants

Octapharma

Status: Completed

Conditions: Emergency Care for Severe Bleeding While on Anticoagulants

Treatments: Other: Expert eCRF; Other: Prothrombin Complex Concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03320603

OPTIPLEX 2

Details and patient eligibility

About

The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or experts' consensus

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years old)

• Receiving oral anticoagulants (VKA or DOAC)

• With a severe bleeding episode meeting at least one of the following criteria

• External hemorrhage which cannot be controlled by usual means or

• Hemodynamic instability: SBP < 90 mmHg or SBP decrease

  • 40 mmHg from usual SBP or mean BP < 65 mmHg or any sign of shock or

• Patient requiring a hemostatic procedure in emergency:

surgery, interventional radiology, endoscopy or

• Need for transfusion of packed red blood cells or

• Hemorrhage jeopardizing the vital or functional prognosis:

  e.g. intracranial hemorrhage, intraspinal hemorrhage, intraocular or retro-ocular hemorrhage, hemothorax, hemoperitoneum, retroperitoneal hemorrhage, hemopericardium, deep muscle hematoma or compartment syndrome, acute digestive hemorrhage, hemarthrosis.

• Admitted in the participating emergency service

• Accepting the collection of his/her own health-related data

Exclusion criteria

• Patient participating in another interventional study
• Pregnant or nursing woman
• Patient under supervision or legal guardianship

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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397 participants in 2 patient groups

Phase 1

Other group

Description:

Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.

Treatment:

Other: Prothrombin Complex Concentrate

Phase 2

Other group

Description:

Prospective collection of data on expert data collection tool (expert eCRF reminding recommendations at each step of the management of severe bleeding). Prothrombin Complex Concentrate given as standard of care.

Treatment:

Other: Prothrombin Complex Concentrate

Other: Expert eCRF