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

O

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)

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

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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