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Completed

NCT Number: NCT03320603

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

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

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Key information

Conditions

Emergency Care for Severe Bleeding While on Anticoagulants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Avignon, Avignon, France

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Expert eCRF

Other

An expert eCRF will be used to guide physicians during the management of patients treated with Vitamin K Agonist or Direct Oral Anticoagulant admitted in emergency units for severe bleeding.

Prothrombin Complex Concentrate

Other

Prothrombin Complex Concentrate given as standard of care

Primary outcomes

  1. Proper Use of PCC Proportion

    Time frame: 20 months

    Proportion of patients for whom the rules of proper use of PCC have been respected

Secondary outcomes

  1. Time to Death

    Time frame: 20 months

    Time to death

  2. Survival Rate

    Time frame: 20 months

    Survival rate

  3. Proportion of Patients with Poor Outcome

    Time frame: 20 months

    Proportion of patients with poor outcome: comparison of phase 1 and phase 2

  4. Predictors of Poor Outcome

    Time frame: 20 months

    Predictors or poor outcome. Potential predictors of poor outcome will be the time from first symptom to admission, the time from first symptom to Prothrombin Complex Concentrate administration, adherence to recommendations regarding proper use of Prothrombin Complex Concentrate, concomitant antiplatelets treatment, medical history or concomitant diseases (cardiac failure, coronary disease, renal failure, diabetes, severe COPD, cancer). For intracranial hemorrhages predictors will include the volume of intracranial hematoma.

  5. Proportion of Patients with Seroconversion

    Time frame: 20 months

    Proportion of Patients with Seroconversion

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

Administration of PCC in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants: Impact of an Expert ECRF on Adherence to Rules of Proper Use and Outcome

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2017
Registry last updated
Jul 27, 2021

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.