Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

Not Applicable

• Conditions: Massive Transfusion; Hemorrhage
• Interventions: Device: Application Protocol

• Registration Number: NCT03074890
• Lead Sponsor: Hospital Universitario de Canarias

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-12-22
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-05
• Last Update Submitted: 2017-03-05
• Study First Posted: 2017-03-09
• Last Update Posted: 2017-03-09
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (cases)	Application Protocol	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

Primary Outcome Measures

Name	Time	Method
30-day Mortality	First 30 day after massive transfusion
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Complejo Universitario de Canarias; 🇪🇸 La Laguna del Marquesado, Santa Cruz de Tenerife, Spain