Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
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
1 other identifier
interventional
397
1 country
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedStudy Start
First participant enrolled
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2020
CompletedJuly 27, 2021
July 1, 2021
3.2 years
October 10, 2017
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proper Use of PCC Proportion
Proportion of patients for whom the rules of proper use of PCC have been respected
20 months
Secondary Outcomes (5)
Time to Death
20 months
Survival Rate
20 months
Proportion of Patients with Poor Outcome
20 months
Predictors of Poor Outcome
20 months
Proportion of Patients with Seroconversion
20 months
Study Arms (2)
Phase 1
OTHERProspective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
Phase 2
OTHERProspective 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.
Interventions
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 given as standard of care
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Patient participating in another interventional study
- Pregnant or nursing woman
- Patient under supervision or legal guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Octapharmalead
Study Sites (26)
Centre Hospitalier d'Avignon
Avignon, 84000, France
Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
Besançon, 25030, France
Clinique Médipole Saint-Roch
Cabestany, 66330, France
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
Caen, 14033, France
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
Caen, 14033, France
Centre Hospitalier Chalon-sur-Saône William Morey
Chalon-sur-Saône, 71321, France
Hôpitaux Civils de Colmar
Colmar, 68024, France
Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
Lyon, 69003, France
Clinique du Tonkin
Lyon, 69100, France
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
Lyon, 69310, France
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
Lyon, 69310, France
Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
Metz, 57530, France
Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
Nantes, 44000, France
Centre Hospitalier de Pau
Pau, 64000, France
Centre Hospitalier de Perpignan
Perpignan, 66000, France
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
Reims, 51092, France
Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
Rennes, 35033, France
Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
Rouen, 76000, France
Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
Strasbourg, 67000, France
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
Strasbourg, 67200, France
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
Strasbourg, 67200, France
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000, France
Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
Toulouse, 31400, France
Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
Tours, 37170, France
Centre Hospitalier de Valence
Valence, 26000, France
Groupe Hospitalier de la Haute-Saône Site de Vesoul
Vesoul, 70000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 25, 2017
Study Start
October 13, 2017
Primary Completion
December 20, 2020
Study Completion
December 20, 2020
Last Updated
July 27, 2021
Record last verified: 2021-07