Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol

NCT03354559 | Completed

• 1 other identifier: 14752/15
• Study Type: observational
• Target: 235
• Locations: 0 countries
• Sites: N/A

Brief Summary

In severe trauma patients, uncontrolled bleeding is a major cause of death, partly caused by trauma-induced coagulopathy (TIC).TIC represents a severe post-traumatic complication associated with increased transfusion requirements and worsened mortality. Fibrinolysis is a central part of the TIC process. Massive Transfusion Protocols (MTPs) were introduced as part of damage control resuscitation, with the aim to facilitate rapid blood product release and to increase adherence to hemostatic resuscitation, In 2013, the Italian Trauma Centers Network (TUN) developed a new treatment algorithm providing early coagulation support (ECS) to control coagulopathy and hemorrhage in major trauma patients with a clinically relevant bleeding risk. The protocol includes the use of fibrinogen concentrate and RBC during initial resuscitation, and the early use of viscoelastic techniques when available (thromboelastometry ROTEM® or thromboelastography TEG). The aim of this multicenter, before and after study was to assess the effects of a new ECS protocol compared to the standard MTP in terms of blood products' consumption and clinical outcome.

Conditions

Major Trauma

Keywords

coagulopathy; trauma; bleeding; fibrinogen; transfusion

Outcome Measures

Primary Outcomes (1)

• Reduction of transfused units

  Amounts of transfused red blood cells, fresh frozen plasma and platelets between the two groups

  24 hours

Secondary Outcomes (2)

• clinical outcome: the effects of the ECS protocol on length of stay

  6 months

• clinical outcome: the effects of the ECS protocol on mortality

  24 hours-28 days

Study Arms (2)

pre-ECS group

Data collection from 01-01-2011 to 31-12-2012. Patients were treated according to a massive transfusion protocol with the following targets: fresh frozen plasma(FFP)/packed red blood cells(PRBCs) ratio ≥ 1:1.5, target platelet count \> 100.000 x 10 9/L

ECS group

Data collection from 01-01-2013 to 31-12-2014. Patients were treated according to the ECS protocol.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive adult patients with major trauma at risk of bleeding admitted to the emergency department of two referral Trauma Centres in Rome, Italy (i.e. Fondazione Policlinico Universitario A. Gemelli and S. Camillo Hospital).

You may qualify if:

• patients with major trauma with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury;
• patient with at least one of the following criteria were present on admission: lactate ≥ 5 mmol/L, BE ≤ - 6, or Hb ≤ 9g/dL on the blood gas analysis and SBP\<90 mmHg

You may not qualify if:

• Patients with cardiac arrest following trauma
• patients who died en route
• patients who were transferred more than six hours after the trauma
• patients or with incomplete medical reports

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• San Camillo Hospital, Rome: collaborator

MeSH Terms

Conditions

Hemostatic Disorders; Wounds and Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant physician; responsible coordinator on major trauma pathway

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2011
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: November 28, 2017

Record last verified: 2017-11