Evaluate treatment with red blood cells, tranexamic acid and in patients with hemorrhage due to severe trauma in patients in pre-hospital phase of care

TRANSFUSION OF RED BLOOD CELLS, TRANEXAMIC ACID AND FIBRINOGEN CONCENTRATE FOR SEVERE TRAUMA HEMORRHAGE AT PRE-HOSPITAL PHASE OF CARE. A PILOT TRIAL. - PRETIC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001867-22-ES

Enrollment

Registered

2018-08-10

Start date

2018-09-27

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TREATMENT OF SEVERE TRAUMA HEMORRHAGE AT PRE-HOSPITAL PHASE OF CARE. MedDRA version: 20.0 Level: LLT Classification code 10019524 Term: Hemorrhage System Organ Class: 100000004866

Interventions

Trade Name: RIASTAP Product Name: RIASTAP Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Human fibrinogen CAS Number: 9001-32-5 Current Sponsor code: FC Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: oAge =18 years AND oPatients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND oEvidence of bleeding or a high bleeding suspicion according to physician judgment OR oPredicted to need transfusion according to TICCS score > 10. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: oMoribund patient with devastating injuries and expected to die within 1-hour OR oKnown objection to blood components transfusion OR oKnown acquired or congenital coagulopathies not related to the actual trauma OR oKnown anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR oKnown Pregnancy OR oSevere isolated traumatic brain injury OR oHemorrhage not related to the actual trauma.

Design outcomes

Primary

Measure	Time frame
Main Objective: •Percentage of RBC returned or confirmed to be transfused compared to RBC delivered at the Sistema d'Emergències Mèdiques (SEM) units H2, G500 and G409. •Percentage of RBC conserved at SEM emergency units (H2, G500 and G409) above 6ºC or less than 2ºC. •Compare TEG6s® parameters that define TIC (R-CK, MA-CFF, MA-CRT and Ly30-CRT) between pre-hospital blood sample and hospital admission blood sample and between control and experimental groups. •Compare all-cause mortality between control and experimental groups at 1, 6 and 24 hours of hospital admittance.;Secondary Objective: •Compare all-cause mortality between control and experimental groups at 48 hours, 30 days and at hospital discharge. •Compare transfusion adverse reactions between the two groups. •Compare thromboembolism events between the two groups. •Compare crystalloid fluid requirements between the two groups at emergency room discharge. •Compare transfusion requirements of RBC, platelets and plasma at emergency room discharge, at 30 days and hospital discharge. •Compare Intensive Care Unit (ICU) and Hospital length stay between the two groups. •Compare ventilator-free days in ICU between the two groups. •Compare water balance at 24 and 72h of ICU stay.;Primary end point(s): •Compare TEG6s® parameters that define TIC (R-CK, MA-CFF, MA-CRT and Ly30-CRT) between pre-hospital blood sample and hospital admission blood sample and between control and experimental groups. •Compare all-cause mortality between control and experimental groups at 1, 6 and 24 hours of hospital admittance.;Timepoint(s) of evaluation of this end point: 24 hours after inclusion in the study	—

Measure

Time frame

Main Objective: •Percentage of RBC returned or confirmed to be transfused compared to RBC delivered at the Sistema d'Emergències Mèdiques (SEM) units H2, G500 and G409. •Percentage of RBC conserved at SEM emergency units (H2, G500 and G409) above 6ºC or less than 2ºC. •Compare TEG6s® parameters that define TIC (R-CK, MA-CFF, MA-CRT and Ly30-CRT) between pre-hospital blood sample and hospital admission blood sample and between control and experimental groups. •Compare all-cause mortality between control and experimental groups at 1, 6 and 24 hours of hospital admittance.;Secondary Objective: •Compare all-cause mortality between control and experimental groups at 48 hours, 30 days and at hospital discharge. •Compare transfusion adverse reactions between the two groups. •Compare thromboembolism events between the two groups. •Compare crystalloid fluid requirements between the two groups at emergency room discharge. •Compare transfusion requirements of RBC, platelets and plasma at emergency room discharge, at 30 days and hospital discharge. •Compare Intensive Care Unit (ICU) and Hospital length stay between the two groups. •Compare ventilator-free days in ICU between the two groups. •Compare water balance at 24 and 72h of ICU stay.;Primary end point(s): •Compare TEG6s® parameters that define TIC (R-CK, MA-CFF, MA-CRT and Ly30-CRT) between pre-hospital blood sample and hospital admission blood sample and between control and experimental groups. •Compare all-cause mortality between control and experimental groups at 1, 6 and 24 hours of hospital admittance.;Timepoint(s) of evaluation of this end point: 24 hours after inclusion in the study

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Secondary

Measure	Time frame
Secondary end point(s): • Compare all-cause mortality between control and experimental groups at 48 hours, 30 days and at hospital discharge. • Compare transfusion adverse reactions between the two groups. • Compare thromboembolism events between the two groups. • Compare crystalloid fluid requirements between the two groups at emergency room discharge. • Compare crystalloid fluid requirements between the two groups at the SEM units. • Compare transfusion requirements of RBC, platelets and plasma at emergency room discharge, at 30 days and hospital discharge. • Compare Intensive Care Unit (ICU) and Hospital length stay between the two groups. • Compare ventilator-free days in ICU between the two groups. • Compare water balance at 24 and 72h of ICU stay.;Timepoint(s) of evaluation of this end point: 30 days after inclusion	—

Measure

Time frame

Secondary end point(s): • Compare all-cause mortality between control and experimental groups at 48 hours, 30 days and at hospital discharge. • Compare transfusion adverse reactions between the two groups. • Compare thromboembolism events between the two groups. • Compare crystalloid fluid requirements between the two groups at emergency room discharge. • Compare crystalloid fluid requirements between the two groups at the SEM units. • Compare transfusion requirements of RBC, platelets and plasma at emergency room discharge, at 30 days and hospital discharge. • Compare Intensive Care Unit (ICU) and Hospital length stay between the two groups. • Compare ventilator-free days in ICU between the two groups. • Compare water balance at 24 and 72h of ICU stay.;Timepoint(s) of evaluation of this end point: 30 days after inclusion

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Countries

Spain

Contacts

Public ContactInvestigator

Banc de Sang i Teixits

cmartinez@idibgi.org00349729402002343

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026