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RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma

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ClinicalTrials.gov Identifier: NCT01545635
Recruitment Status : Terminated (The Interim analysis (100 patients) revealed a possible harm to patients randomised to the fresh frozen plasma (FFP) treatment arm.)
First Posted : March 7, 2012
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Univ.-Doz. Dr. Petra Innerhofer, Medical University Innsbruck

Study Description
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Brief Summary:

Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.

Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.

In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.

At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).

The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.

Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.


Condition or disease Intervention/treatment Phase
Major Trauma Drug: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate Drug: Fresh Frozen Plasma blood type 0, A, B and AB Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
Study Start Date : March 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Coagulation factor concentrates Drug: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate

Fibrinogen concentrate Dose: 50 mg/kg BW fibrinogen concentrate if FIBTEM A10<7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single vial (1g) over 5 min

Prothrombin complex concentrate Dose: 20IE/kg BW PCC if EXTEM CT >90sec and FIBTEM A10>7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min

FXIII concentrate Dose: 20 IU/kg BW Fibrogammin® P will be administered with the second dose of fibrinogen concentrate (=100 mg/kg) and if FXIII decreases below 60% as detected by laboratory measurements.

Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min
Active Comparator: Fresh Frozen Plasma Drug: Fresh Frozen Plasma blood type 0, A, B and AB
Fresh Frozen Plasma Dose: 15ml/kg BW if FibTEM A10 <7mm and/or ExTEM CT>90sec. Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single U (200mL) over 5 min


Outcome Measures
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Primary Outcome Measures :
  1. Multiple Organ Failure (MOF) [ Time Frame: Variable until 24h on ICU at the end of the IMP-administration ]
    Difference in the MOF as assessed by the Sequential Organ Failure Assessment score (SOFA) between treatment groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects =/> 18 years and =/< 80 years
  2. Major trauma (ISS > 15)
  3. Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient

  4. Presence of coagulopathy defined by ROTEM assays as follows,

    • Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of < 7 mm after 10 min)
    • Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of > 90 sec)

Exclusion Criteria:

  1. Lethal injury
  2. CPR on the scene,
  3. Isolated brain injury, burn injury
  4. Avalanche injury
  5. Administration of FFP or coagulation factor concentrates before ED admission
  6. Delayed (> 6hours after trauma) admittance to ED
  7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury
  8. Known history of severe allergic reaction to plasma products
  9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency
  10. Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year
  11. Patients with a body weight < 45kg and > 150kg
  12. Patients that are known to be pregnant
  13. Jehova's Witness
  14. Known participation in another clinical trial
  15. Patient with known refusal of a participation in this clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545635


Locations
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Austria
Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine
Innsbruck, Tyrol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Univ.-Doz. Dr. Petra Innerhofer, Principal Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01545635     History of Changes
Other Study ID Numbers: RETIC
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Keywords provided by Univ.-Doz. Dr. Petra Innerhofer, Medical University Innsbruck:
Major trauma
Injury Severity Score
ISS > 15
clinical signs
 risk of blood loss
coagulopathy
rotational thrombelastometry
ROTEM
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
 Cardiovascular Diseases
Hemorrhagic Disorders
Thrombin
Hemostatics
Coagulants