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

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

Study Overview

• Status: Completed
• Conditions: Emergency Care for Severe Bleeding While on Anticoagulants
• Intervention / Treatment: Other: Prothrombin Complex Concentrate; Other: Expert eCRF

• Study Type: Interventional
• Enrollment (Actual): 397
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Centre Hospitalier d'Avignon
  • Besançon, France, 25030
    • Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
  • Cabestany, France, 66330
    • Clinique Médipole Saint-Roch
  • Caen, France, 14033
    • Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
  • Caen, France, 14033
    • Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
  • Chalon-sur-Saône, France, 71321
    • Centre Hospitalier Chalon-sur-Saône William Morey
  • Colmar, France, 68024
    • Hopitaux Civils de Colmar
  • Lyon, France, 69100
    • Clinique du Tonkin
  • Lyon, France, 69003
    • Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
  • Lyon, France, 69310
    • Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
  • Lyon, France, 69310
    • Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
  • Metz, France, 57530
    • Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
  • Pau, France, 64000
    • Centre Hospitalier de Pau
  • Perpignan, France, 66000
    • Centre Hospitalier de Perpignan
  • Reims, France, 51092
    • Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou
  • Rouen, France, 76000
    • Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
  • Strasbourg, France, 67000
    • Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
  • Strasbourg, France, 67200
    • Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
  • Strasbourg, France, 67200
    • Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
  • Toulon, France, 83000
    • Hôpital d'Instruction des Armées Sainte-Anne
  • Toulouse, France, 31400
    • Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
  • Tours, France, 37170
    • Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
  • Valence, France, 26000
    • Centre Hospitalier de Valence
  • Vesoul, France, 70000
    • Groupe Hospitalier de la Haute-Saône Site de Vesoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Phase 1; Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.	Other: Prothrombin Complex Concentrate; Prothrombin Complex Concentrate given as standard of care
OTHER: Phase 2; 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.	Other: Prothrombin Complex Concentrate; Prothrombin Complex Concentrate given as standard of care; Other: Expert eCRF; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proper Use of PCC Proportion	Proportion of patients for whom the rules of proper use of PCC have been respected	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Death	Time to death	20 months
Survival Rate	Survival rate	20 months
Proportion of Patients with Poor Outcome	Proportion of patients with poor outcome: comparison of phase 1 and phase 2	20 months
Predictors of Poor Outcome	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.	20 months
Proportion of Patients with Seroconversion	Proportion of Patients with Seroconversion	20 months

Collaborators and Investigators

• Sponsor: Octapharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): December 20, 2020

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Hemorrhage; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: OPTIPLEX 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No