Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol (PHM)

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

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 Overview

• Status: Unknown
• Conditions: Hemorrhage; Massive Transfusion
• Intervention / Treatment: Device: Application Protocol

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz de Tenerife
    • La Laguna del Marquesado, Santa Cruz de Tenerife, Spain, 38320
      • Recruiting
      • Complejo Universitario de Canarias
      • Contact: Magali Gonzaàlez- Colaço Harmand, MD,PhD; Phone Number: 34922678115; Email: magaligch@hotmail.com
      • Contact: Ana Aldea, MD, PhD; Phone Number: 34922678115; Email: a.aldea@gmail.com
      • Principal Investigator: Vanesa González Fariña, MD
      • Sub-Investigator: María Martín Lorenzo, MD
      • Sub-Investigator: Nuria Montón Giménez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias
• Investigators: Principal Investigator: Vanesa González Fariña, MD, Hospital Universitario de Canarias; Study Director: Juan J Jiménez Rivera, MD, Hospital Universitario de Canarias; Study Director: José M Raya Sánchez, MD, Hospital Universitario de Canarias

Publications and helpful links

General Publications

• 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. Erratum In: Crit Care. 2007 Apr 24;11(2):414.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: March 5, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 5, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TRAMA-05-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided