경구용 항응고제를 투여받는 중 심한 출혈로 응급실에 입원한 환자의 프로트롬빈 복합 농축액 사용
경구용 항응고제 투여 중 심한 출혈로 응급실에 입원한 환자의 PCC 투여: 적절한 사용 및 결과 규칙 준수에 대한 전문가 ECRF의 영향
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
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Avignon, 프랑스, 84000
- Centre Hospitalier d'Avignon
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Besançon, 프랑스, 25030
- Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
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Cabestany, 프랑스, 66330
- Clinique Médipole Saint-Roch
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Caen, 프랑스, 14033
- Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
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Caen, 프랑스, 14033
- Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
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Chalon-sur-Saône, 프랑스, 71321
- Centre Hospitalier Chalon-sur-Saône William Morey
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Colmar, 프랑스, 68024
- Hôpitaux Civils de Colmar
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Lyon, 프랑스, 69003
- Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
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Lyon, 프랑스, 69100
- Clinique du Tonkin
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Lyon, 프랑스, 69310
- Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
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Lyon, 프랑스, 69310
- Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
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Metz, 프랑스, 57530
- Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
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Nantes, 프랑스, 44000
- Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
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Pau, 프랑스, 64000
- Centre Hospitalier de Pau
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Perpignan, 프랑스, 66000
- Centre Hospitalier de Perpignan
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Reims, 프랑스, 51092
- Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
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Rennes, 프랑스, 35033
- Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
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Rouen, 프랑스, 76000
- Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
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Strasbourg, 프랑스, 67000
- Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
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Strasbourg, 프랑스, 67200
- Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
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Strasbourg, 프랑스, 67200
- Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
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Toulon, 프랑스, 83000
- Hôpital d'Instruction des Armées Sainte-Anne
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Toulouse, 프랑스, 31400
- Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
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Tours, 프랑스, 37170
- Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
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Valence, 프랑스, 26000
- Centre Hospitalier de Valence
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Vesoul, 프랑스, 70000
- Groupe Hospitalier de la Haute-Saône Site de Vesoul
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Adult patients (≥ 18 years old)
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Receiving oral anticoagulants (VKA or DOAC)
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With a severe bleeding episode meeting at least one of the following criteria
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External hemorrhage which cannot be controlled by usual means or
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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
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Need for transfusion of packed red blood cells or
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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.
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Admitted in the participating emergency service
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Phase 1
Prospective collection of data on a standard eCRF (without reminders of recommendations). Prothrombin Complex Concentrate given as standard of care. |
Prothrombin Complex Concentrate given as standard of care |
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다른: 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. |
Prothrombin Complex Concentrate given as standard of care 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participants for Whom All Conditions of Proper Use of PCC Have Been Respected
기간: at Day 0
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The count of participants for whom all conditions of use of PCC (Prothrombin Complex Concentrate) have been respected. Conditions of proper use of PCC included respect of indication, dose, administration, concomitant administration of other medications and monitoring. A detailed description of conditions can be seen from Section 10 of the SAP. Higher counts indicate better outcome. |
at Day 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Survival Probability
기간: 30 Days
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Survival probability at 30 days was estimated using a Kaplan Meier model. Higher numbers indicate better outcome. |
30 Days
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Participants With Bad Outcome
기간: 30 Days
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The count of participants with bad outcome was compared between Phase 1 and Phase 2. The outcome was evaluated using the Glasgow Outcome Scale (GOS). The five possible outcome categories of the GOS are (1) death, (2) persistent vegetative state, (3) severe disability, (4) moderate disability and (5) good recovery. GOS between 1 and 3 at Day 7 and no GOS higher than 3 at Day 30 or loss of vision at Day 7 not recovered at Day 30 or death of the participant were considered bad outcomes. Lower counts of participants indicate better outcome. |
30 Days
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .