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Clinical Trials/NCT03074890
NCT03074890UnknownNot Applicable

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

Hospital Universitario de Canarias2 sites in 1 country30 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
2
Primary Endpoint
30-day Mortality

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

30-day Mortality

Time Frame: First 30 day after massive transfusion

Time to Hemostasis

Time Frame: 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 Outcomes

  • Amount of Blood Products Given From Hemostasis to 24 Hours After(24 hours after admission)
  • Incidence of Massive Transfusion Related Serious Adverse Events(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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

María del Carmen Martín Lorenzo

Dr

Hospital Universitario de Canarias

Study Sites (2)

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