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

Primary Purpose

Emergency Care for Severe Bleeding While on Anticoagulants

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Expert eCRF
Prothrombin Complex Concentrate
Sponsored by
Octapharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Emergency Care for Severe Bleeding While on Anticoagulants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier d'Avignon
  • Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
  • Clinique Médipole Saint-Roch
  • Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
  • Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
  • Centre Hospitalier Chalon-sur-Saône William Morey
  • Hôpitaux Civils de Colmar
  • Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
  • Clinique du Tonkin
  • Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
  • Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
  • Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
  • Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
  • Centre Hospitalier de Pau
  • Centre Hospitalier de Perpignan
  • Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
  • Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
  • Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
  • Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
  • Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
  • Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
  • Hôpital d'Instruction des Armées Sainte-Anne
  • Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
  • Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
  • Centre Hospitalier de Valence
  • Groupe Hospitalier de la Haute-Saône Site de Vesoul

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Phase 1

Phase 2

Arm Description

Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2017
Last Updated
July 26, 2021
Sponsor
Octapharma
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1. Study Identification

Unique Protocol Identification Number
NCT03320603
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Care for Severe Bleeding While on Anticoagulants

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Other
Arm Description
Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care.
Arm Title
Phase 2
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Expert eCRF
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Prothrombin Complex Concentrate
Intervention Description
Prothrombin Complex Concentrate given as standard of care
Primary Outcome Measure Information:
Title
Proper Use of PCC Proportion
Description
Proportion of patients for whom the rules of proper use of PCC have been respected
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Time to Death
Description
Time to death
Time Frame
20 months
Title
Survival Rate
Description
Survival rate
Time Frame
20 months
Title
Proportion of Patients with Poor Outcome
Description
Proportion of patients with poor outcome: comparison of phase 1 and phase 2
Time Frame
20 months
Title
Predictors of Poor Outcome
Description
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.
Time Frame
20 months
Title
Proportion of Patients with Seroconversion
Description
Proportion of Patients with Seroconversion
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre Hospitalier d'Avignon
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Clinique Médipole Saint-Roch
City
Cabestany
ZIP/Postal Code
66330
Country
France
Facility Name
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Hospitalier Chalon-sur-Saône William Morey
City
Chalon-sur-Saône
ZIP/Postal Code
71321
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Clinique du Tonkin
City
Lyon
ZIP/Postal Code
69100
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Name
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
City
Metz
ZIP/Postal Code
57530
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Hospitalier de Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
City
Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Groupe Hospitalier de la Haute-Saône Site de Vesoul
City
Vesoul
ZIP/Postal Code
70000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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