NCT03074890

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

December 22, 2016

Last Update Submit

March 5, 2017

Conditions

Massive TransfusionHemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • Amount of Blood Products Given From Hemostasis to 24 Hours After

    24 hours after admission

Study Arms (2)

Intervention (cases)

EXPERIMENTAL

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

No Intervention (control))

NO INTERVENTION

all patients with massive haemorrhage in which the massive transfusion protocol didn´t apply

Interventions

Application ProtocolDEVICE

Application lMassive Transfusion Protocol

Intervention (cases)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with massive haemorrhage and surgery
  • Informed consent

You may not qualify if:

  • \<18 years old patients
  • Patients didn´t want to participate in this study
  • Patients were participated in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Universitario de Canarias

Laguna del Marquesado, Santa Cruz de Tenerife, 38320, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 17298665BACKGROUND

  • 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.

    PMID: 16763487BACKGROUND

  • 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.

    PMID: 18090009BACKGROUND

  • 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.

    PMID: 23789799BACKGROUND

  • 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.

    PMID: 19131804BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vanesa González Fariña, MD

    Hospital Universitario de Canarias

    PRINCIPAL INVESTIGATOR

  • Juan J Jiménez Rivera, MD

    Hospital Universitario de Canarias

    STUDY DIRECTOR

  • José M Raya Sánchez, MD

    Hospital Universitario de Canarias

    STUDY DIRECTOR

Central Study Contacts

Vanesa González Fariña, MD

CONTACT

vanefari@outlook.com

María Martín Lorenzo, MD

CONTACT

mcmartín-lorenzo@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 22, 2016

First Posted

March 9, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

ES(1)