凝血酶原复合浓缩物在接受口服抗凝剂治疗时因严重出血而入急诊室的患者中的应用
在接受口服抗凝剂治疗时因严重出血而进入急诊室的患者使用 PCC：专家 ECRF 对遵守正确使用规则和结果的影响
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Avignon、法国、84000
- Centre Hospitalier d'Avignon
-
Besançon、法国、25030
- Centre Hospitalier Régional Universitaire de Besançon Hôpital Jean Minjoz
-
Cabestany、法国、66330
- Clinique Médipole Saint-Roch
-
Caen、法国、14033
- Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service de Réanimation
-
Caen、法国、14033
- Centre Hospitalier Universitaire de Caen Hôpital Côte de Nacre Service des Urgences
-
Chalon-sur-Saône、法国、71321
- Centre Hospitalier Chalon-sur-Saône William Morey
-
Colmar、法国、68024
- Hôpitaux Civils de Colmar
-
Lyon、法国、69003
- Hospices Civils de Lyon Hopital Edouard Herriot Service des Urgences
-
Lyon、法国、69100
- Clinique du Tonkin
-
Lyon、法国、69310
- Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service de Réanimation
-
Lyon、法国、69310
- Hospices Civils de Lyon Centre Hospitalier Lyon-Sud Service des Urgences
-
Metz、法国、57530
- Centre Hospitalier Régional Metz-Thionville Hôpital Mercy
-
Nantes、法国、44000
- Centre Hospitalier Universitaire de Nantes Hôtel-Dieu
-
Pau、法国、64000
- Centre Hospitalier de Pau
-
Perpignan、法国、66000
- Centre Hospitalier de Perpignan
-
Reims、法国、51092
- Centre Hospitalier Universitaire de Reims Hôpital Maison Blanche
-
Rennes、法国、35033
- Centre Hospitalier Universitaire de Rennes Hôpital Pontchaillou
-
Rouen、法国、76000
- Centre Hospitalier Universitaire de Rouen Hôpital Charles-Nicolle
-
Strasbourg、法国、67000
- Centre Hospitalier Universitaire de Strasbourg Nouvel Hôpital Civil Service des Urgences
-
Strasbourg、法国、67200
- Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service de Réanimation
-
Strasbourg、法国、67200
- Centre Hospitalier Universitaire de Strasbourg Hôpital de Hautepierre Service des Urgences
-
Toulon、法国、83000
- Hôpital d'Instruction des Armées Sainte-Anne
-
Toulouse、法国、31400
- Centre Hospitalier Universitaire de Toulouse Hôpitaux Purpan et Rangueil
-
Tours、法国、37170
- Centre Hospitalier Régional Universitaire de Tours Hôpital Trousseau
-
Valence、法国、26000
- Centre Hospitalier de Valence
-
Vesoul、法国、70000
- Groupe Hospitalier de la Haute-Saône Site de Vesoul
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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 |
|
其他：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participants for Whom All Conditions of Proper Use of PCC Have Been Respected
大体时间：at Day 0
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Survival Probability
大体时间：30 Days
|
Survival probability at 30 days was estimated using a Kaplan Meier model. Higher numbers indicate better outcome. |
30 Days
|
|
Participants With Bad Outcome
大体时间：30 Days
|
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
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.