Clinical trial NCT03320603: Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Care for Severe Bleeding While on Anticoagulants
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Proper Use of PCC Proportion
timeFrame: 20 months
Secondary outcomes:
measure: Time to Death
timeFrame: 20 months
measure: Survival Rate
timeFrame: 20 months
measure: Proportion of Patients with Poor Outcome
timeFrame: 20 months
measure: Predictors of Poor Outcome
timeFrame: 20 months
measure: Proportion of Patients with Seroconversion
timeFrame: 20 months
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
city: Cabestany
country: France
facility: Clinique Médipole Saint-Roch
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier Chalon-sur-Saône William Morey
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Lyon
country: France
facility: Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
city: Lyon
country: France
facility: Clinique du Tonkin
city: Lyon
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
city: Lyon
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
city: Metz
country: France
facility: Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Reims
country: France
facility: Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
city: Tours
country: France
facility: Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Vesoul
country: France
facility: Groupe Hospitalier de la Haute-Saône Site de Vesoul
Study officials:
References: