Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

Study Overview
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Brief Summary
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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.

Official Title
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Observational Study to Assess the Safety and Clinical Effectiveness of the Hospital Universitario de Canarias Massive Transfusion Protocol

Conditions
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Massive Transfusion, Hemorrhage

Intervention / Treatment
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* Device: Application Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (cases)<br>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: Application Protocol<br>* Application lMassive Transfusion Protocol<br>|
| No Intervention: No Intervention (control))<br>all patients with massive haemorrhage in which the massive transfusion protocol didn´t apply | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Mortality |  | First 30 day after massive transfusion | 
| Time to Hemostasis | Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department arrival. | admission to hospital discharge or 30 days, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Massive Transfusion Related Serious Adverse Events | Immunological reactions No immunological reactions | 30 days | 
| Severity of coagulopathy associated with high transfusion ratios |  | 30 days post admission | 
| Amount of Blood Products Given to Hemostasis |  | 24 hours from randomization | 
| Amount of Blood Products Given From Hemostasis to 24 Hours After |  | 24 hours after admission |