Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

Hemorrhage Clinical Trial

— PHM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074890
• Other study ID #: TRAMA-05-2014
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2016
• Last updated: March 5, 2017
• Start date: January 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Hospital Universitario de Canarias
• Contact: Vanesa González Fariña, MD
• Email: vanefari[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Massive Transfusion

Intervention

Device:
• Application Protocol
Application lMassive Transfusion Protocol

Locations

Country	Name	City	State
Spain	Complejo Universitario de Canarias	La Laguna del Marquesado	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View Citation

Leal-Noval SR, Muñoz M, Asuero M, Contreras E, García-Erce JA, Llau JV, Moral V, Páramo 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. — View 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. — View Citation

Spahn DR, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar 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. Erratum in: Crit Care. 2007 Apr 24;11(2):414. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Mortality		First 30 day after massive transfusion
Primary	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	Incidence of Massive Transfusion Related Serious Adverse Events	Immunological reactions No immunological reactions	30 days
Secondary	Severity of coagulopathy associated with high transfusion ratios		30 days post admission
Secondary	Amount of Blood Products Given to Hemostasis		24 hours from randomization
Secondary	Amount of Blood Products Given From Hemostasis to 24 Hours After		24 hours after admission