Emergency Care for Severe Bleeding While on AnticoagulantsNCT03320603
Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
A study testing Expert eCRF and Prothrombin Complex Concentrate in people with Emergency Care for Severe Bleeding While on Anticoagulants, run by Octapharma at 26 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Care for Severe Bleeding While on Anticoagulants
- What is being tested?
- Expert eCRF and Prothrombin Complex Concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 26 sitesFrance
- Study dates
- 13 Oct 2017to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Patient participating in another interventional study
- Pregnant or nursing woman
- Patient under supervision or legal guardianship
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Centre Hospitalier d'Avignon
Avignon, 84000
Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
Besançon, 25030
Clinique Médipole Saint-Roch
Cabestany, 66330
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
Caen, 14033
Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
Caen, 14033
Centre Hospitalier Chalon-sur-Saône William Morey
Chalon-sur-Saône, 71321
Hôpitaux Civils de Colmar
Colmar, 68024
Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
Lyon, 69003
Clinique du Tonkin
Lyon, 69100
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
Lyon, 69310
Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
Lyon, 69310
Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
Metz, 57530
Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
Nantes, 44000
Centre Hospitalier de Pau
Pau, 64000
Centre Hospitalier de Perpignan
Perpignan, 66000
Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
Reims, 51092
Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
Rennes, 35033
Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
Rouen, 76000
Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
Strasbourg, 67000
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
Strasbourg, 67200
Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
Strasbourg, 67200
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83000
Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
Toulouse, 31400
Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
Tours, 37170
Centre Hospitalier de Valence
Valence, 26000
Groupe Hospitalier de la Haute-Saône Site de Vesoul
Vesoul, 70000
About this study
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
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
- Being tested
- Expert eCRF, Prothrombin Complex Concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert eCRFOther
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 ConcentrateOther
Prothrombin Complex Concentrate given as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Other | Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care. Receives: Other: Prothrombin Complex Concentrate |
| Phase 2 | Other | 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. Receives: Other: Expert eCRF; Other: Prothrombin Complex Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper Use of PCC Proportion
Proportion of patients for whom the rules of proper use of PCC have been respected
Measured: 20 months
Secondary outcomes (5)
Time to Death
Time to death
Measured: 20 months
Survival Rate
Survival rate
Measured: 20 months
Proportion of Patients with Poor Outcome
Proportion of patients with poor outcome: comparison of phase 1 and phase 2
Measured: 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.
Measured: 20 months
Proportion of Patients with Seroconversion
Proportion of Patients with Seroconversion
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start13 Oct 2017
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Care for Severe Bleeding While on AnticoagulantsStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320603
- Sponsor's protocol ID
- OPTIPLEX 2
- Status last verified
- Jul 2021
- First submitted
- 10 Oct 2017
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320603
- Acronym / sponsor ID
- OPTIPLEX 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Other | Other: Prothrombin Complex ConcentrateProspective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care. |
| Phase 2 | Other | Other: Expert eCRF, Other: Prothrombin Complex ConcentrateProspective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- Patient participating in another interventional study
- Pregnant or nursing woman
- Patient under supervision or legal guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert eCRFAn 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. | Other | Phase 2 |
| Prothrombin Complex ConcentrateProthrombin Complex Concentrate given as standard of care | Other | Phase 1, Phase 2 |
Primary outcome
Proper Use of PCC Proportion
Time frame: 20 months
Proportion of patients for whom the rules of proper use of PCC have been respected
5 secondary outcomes
Time to Death
Time frame: 20 months
Survival Rate
Time frame: 20 months
Proportion of Patients with Poor Outcome
Time frame: 20 months
Predictors of Poor Outcome
Time frame: 20 months
Proportion of Patients with Seroconversion
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert eCRF and Prothrombin Complex Concentrate in people with Emergency Care for Severe Bleeding While on Anticoagulants, run by Octapharma at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proper Use of PCC Proportion (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.