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

Not Applicable

Completed

• Conditions: Emergency Care for Severe Bleeding While on Anticoagulants
• Interventions: Other: Prothrombin Complex Concentrate; Other: Expert eCRF

• Registration Number: NCT03320603
• Lead Sponsor: Octapharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study Start: 2017-10-13
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1	Prothrombin Complex Concentrate	Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
Phase 2	Expert eCRF	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.
Phase 2	Prothrombin Complex Concentrate	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.

Primary Outcome Measures

Name	Time	Method
Proper Use of PCC Proportion	20 months	Proportion of patients for whom the rules of proper use of PCC have been respected

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Groupe Hospitalier de la Haute-Saône Site de Vesoul; 🇫🇷 Vesoul, France

Centre Hospitalier de Pau; 🇫🇷 Pau, France

Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation; 🇫🇷 Strasbourg, France

Centre Hospitalier Universitaire de Nantes Hôtel-Dieu; 🇫🇷 Nantes, France

Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou; 🇫🇷 Rennes, France

Clinique Médipole Saint-Roch; 🇫🇷 Cabestany, France

Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences; 🇫🇷 Lyon, France

Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz; 🇫🇷 Besançon, France

Centre Hospitalier d'Avignon; 🇫🇷 Avignon, France

Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation; 🇫🇷 Caen, France

Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences; 🇫🇷 Caen, France

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche; 🇫🇷 Reims, France

Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau; 🇫🇷 Tours, France

Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation; 🇫🇷 Lyon, France

Centre Hospitalier Chalon-sur-Saône William Morey; 🇫🇷 Chalon-sur-Saône, France

Clinique du Tonkin; 🇫🇷 Lyon, France

Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences; 🇫🇷 Lyon, France

Centre Hospitalier Régional Metz-Thionville Hôpital Mercy; 🇫🇷 Metz, France

Centre Hospitalier de Perpignan; 🇫🇷 Perpignan, France

Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle; 🇫🇷 Rouen, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France

Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil; 🇫🇷 Toulouse, France

Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences; 🇫🇷 Strasbourg, France

Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences; 🇫🇷 Strasbourg, France

Centre Hospitalier de Valence; 🇫🇷 Valence, France