Hemorrhage Clinical Trial
— PHMOfficial title:
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.
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 didnĀ“t want to participate in this study - Patients were participated in other studies |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Universitario de Canarias | La Laguna del Marquesado | Santa Cruz de Tenerife |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario de Canarias |
Spain,
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
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 |
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