Clinical trial NCT03074890: Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol
Official title: Observational Study to Assess the Safety and Clinical Effectiveness of the Hospital Universitario de Canarias Massive Transfusion Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Massive Transfusion
Hemorrhage
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-day Mortality
timeFrame: First 30 day after massive transfusion
measure: Time to Hemostasis
timeFrame: admission to hospital discharge or 30 days, whichever comes first
Secondary outcomes:
measure: Incidence of Massive Transfusion Related Serious Adverse Events
timeFrame: 30 days
measure: Severity of coagulopathy associated with high transfusion ratios
timeFrame: 30 days post admission
measure: Amount of Blood Products Given to Hemostasis
timeFrame: 24 hours from randomization
measure: Amount of Blood Products Given From Hemostasis to 24 Hours After
timeFrame: 24 hours after admission
Other outcomes:
Locations:
city: La Laguna del Marquesado
country: Spain
facility: Complejo Universitario de Canarias
state: Santa Cruz de Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: Vanesa González Fariña, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Juan J Jiménez Rivera, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario de Canarias
name: José M Raya Sánchez, MD
role: STUDY_DIRECTOR
References:
citation: Spahn DR, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Gordini G, Stahel PF, Hunt BJ, Komadina R, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R; Task Force for Advanced Bleeding Care in Trauma. Management of bleeding following major trauma: a European guideline. Crit Care. 2007;11(1):R17. doi: 10.1186/cc5686.
citation: Malone DL, Hess JR, Fingerhut A. Massive transfusion practices around the globe and a suggestion for a common massive transfusion protocol. J Trauma. 2006 Jun;60(6 Suppl):S91-6. doi: 10.1097/01.ta.0000199549.80731.e6.
citation: Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13. doi: 10.1097/TA.0b013e3181271ba3.
citation: Leal-Noval SR, Munoz M, Asuero M, Contreras E, Garcia-Erce JA, Llau JV, Moral V, Paramo JA, Quintana M; Spanish Society of Anaesthesiology and Reanimation (SEDAR); Spanish Society of Haematology and Haemotherapy (SEHH); Spanish Society of Hospital Pharmacy (SEFH); Spanish Society of Intensive Care, Critical and Coronary Units (SEMICYUC); Spanish Society of Thrombosis and Haemostasis (SETH); Spanish Society of Blood Transfusion (SETS). [2013: The Seville document on consensus on the alternatives to allogenic blood transfusion. Update to the Seville document. Spanish Societies of Anaesthesiology (SEDAR), Haematology and Haemotherapy (SEHH), Hospital Pharmacy (SEFH), Critical Care Medicine (SEMICYUC), Thrombosis and Haemostasis (SETH) and Blood Transfusion (SETS)]. Farm Hosp. 2013 May-Jun;37(3):209-35. doi: 10.7399/FH.2013.37.3.133. Spanish.
citation: Cotton BA, Au BK, Nunez TC, Gunter OL, Robertson AM, Young PP. Predefined massive transfusion protocols are associated with a reduction in organ failure and postinjury complications. J Trauma. 2009 Jan;66(1):41-8; discussion 48-9. doi: 10.1097/TA.0b013e31819313bb.