Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

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Status

Sponsorlar

Hospital Universitario de Canarias

KLINIK SINAQ: NCT03074890

BioSeek: NCT03074890

Açar sözlər

Mücərrəd

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.

Tarixlər

Son Doğrulandı:	02/28/2017
İlk təqdim:	12/21/2016
Təxmini qeydiyyat təqdim edildi:	03/04/2017
İlk Göndərmə:	03/08/2017
Son Yeniləmə Göndərildi:	03/04/2017
Son Yeniləmə Göndərildi:	03/08/2017
Həqiqi Təhsilin Başlama Tarixi:	12/31/2014
Təxmini İlkin Tamamlanma Tarixi:	05/31/2017
Təxmini İşin Tamamlanma Tarixi:	07/31/2017

Vəziyyət və ya xəstəlik

Massive Transfusion

Hemorrhage

Müdaxilə / müalicə

Device: Intervention (cases)

Faza

Qol Qrupları

Qol	Müdaxilə / müalicə
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

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	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

Nəticə

İlkin nəticə tədbirləri

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.

İkincili Nəticə Tədbirləri

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]