Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

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状態

スポンサー

Hospital Universitario de Canarias

臨床試験: NCT03074890

BioSeek: NCT03074890

キーワード

概要

Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the loss of 4-5 cc/kg/h or more, and haemorrhage shock.

Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction. In many cases massive transfusion is needed to stabilize the vital function. This massive transfusion can have serious side effects (infectious and immunologic and no immunologic reactions) and increase the morbidity and mortality.

Massive transfusion protocols improve the survival in severe trauma injury patients. The transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet concentrates have decreased the severity of trauma induced coagulopathy.

Recently several studies have shown the benefit of massive transfusion protocols with high transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and aggressive transfusion improve the outcomes and the resources.

Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce the variability in the clinic experience, to reduce the transfusion necessities and to assure an safe treatment with blood products.

So with this study the investigators will evaluate if the goals of this Protocol are followed and if the use of this Protocol is really safe and efficient.

日付

最終確認済み:	02/28/2017
最初に提出された:	12/21/2016
提出された推定登録数:	03/04/2017
最初の投稿:	03/08/2017
最終更新が送信されました:	03/04/2017
最終更新日:	03/08/2017
実際の研究開始日:	12/31/2014
一次完了予定日:	05/31/2017
研究完了予定日:	07/31/2017

状態または病気

Massive Transfusion

Hemorrhage

介入/治療

Device: Intervention (cases)

段階

アームグループ

腕	介入/治療
Experimental: Intervention (cases) Intervention: Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC:FFP:PLT) and conventional coagulation tests guiding further resuscitation with blood products and procoagulant factors	Device: Intervention (cases) Application lMassive Transfusion Protocol
No Intervention: No Intervention (control)) all patients with massive haemorrhage in which the massive transfusion protocol didn´t apply

適格基準

研究の対象となる年齢	18 Years に 18 Years
研究に適格な性別	All
健康なボランティアを受け入れる	はい
基準	Inclusion Criteria: - Patients with massive haemorrhage and surgery - Informed consent Exclusion Criteria: - <18 years old patients - Patients didn´t want to participate in this study - Patients were participated in other studies

結果

主な結果の測定

1. 30-day Mortality [First 30 day after massive transfusion]

2. Time to Hemostasis [admission to hospital discharge or 30 days, whichever comes first]

Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department arrival.

二次的な結果の測定

1. Incidence of Massive Transfusion Related Serious Adverse Events [30 days]

Immunological reactions No immunological reactions

2. Severity of coagulopathy associated with high transfusion ratios [30 days post admission]

3. Amount of Blood Products Given to Hemostasis [24 hours from randomization]

4. Amount of Blood Products Given From Hemostasis to 24 Hours After [24 hours after admission]

Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

キーワード

canaria

hemorrhage

概要

日付

状態または病気

介入/治療

段階

アームグループ

適格基準

結果

科学に裏打ちされた最も完全な薬草データベース