Major Trauma Clinical Trial
Official title:
Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol. A Before and After Study
Verified date | November 2017 |
Source | Policlinico Universitario Agostino Gemelli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 235 |
Est. completion date | December 31, 2014 |
Est. primary completion date | December 31, 2014 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Policlinico Universitario Agostino Gemelli | San Camillo Hospital, Rome |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of transfused units | Amounts of transfused red blood cells, fresh frozen plasma and platelets between the two groups | 24 hours | |
Secondary | clinical outcome: the effects of the ECS protocol on length of stay | Describe the effects on hospital stay and ICU stay, limited to the survivors beyond the first 24 hours, between the two groups (pre-ECS and ECS) | 6 months | |
Secondary | clinical outcome: the effects of the ECS protocol on mortality | Evaluate any differences in mortality within the first 24 hours and within 28 days since admission between the two groups (pre-ECS and ECS period). | 24 hours-28 days |
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