Trial document




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  DRKS00009559

Trial Description

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Title

Prehospital Evaluation and Detection of Induced Coagulopathy in Trauma

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Trial Acronym

PREDICT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The first goal of this study is to evaluate if trauma patients have already in the prehospital setting a compromised blood coagulation (TIC = Trauma Induced Coaguloptahy). The second goal is to examine wether patients with a trauma induced coagulopthy need more ofter blood and blood products during the 24 hours. The third goal is to evaluate if these patients have a higher 28 day mortality.


Hypothesis:
Patiensn with a sever multi system trauma - as well as patients with a single, severe injury - have a compromised coagulation in the prehospital setting.

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Brief Summary in Scientific Language

The first goal of this study is to evaluate if trauma patients have already in the prehospital setting a compromised blood coagulation (TIC = Trauma Induced Coaguloptahy). The second goal is to examine wether patients with a trauma induced coagulopthy need more ofter blood and blood products during the 24 hours. The third goal is to evaluate if these patients have a higher 28 day mortality.


Hypothesis / Questions:
Patiensn with a sever multi system trauma - as well as patients with a single, severe injury - have a compromised coagulation in the prehospital setting.

1. Do trauma patients have a TIC in the prehospital setting? (T0 = prehospital setting / T1 = shock trauma room)

2. Do these Patienten need more blood and blood products during their first 24h of treatment (T2 = 24h after injury)

3. Do thes patients have a higher 28 day mortality (T3 = 28 days after trauma)

Study design:
- observational study
- prospective
- mono centric
- open, not randomised

Parameters of special interest: Clotting-Time (CT), Clot-Formation-Time (CFT), Clot-Firmness (CF) A10 (Amplitude 10min past CT) and MCF (Maximum-Clot-Firmness) after 30min in EXTEM / FIBTEM of the thrombelastographie.

time stamps:
T0: Prehospital setting
T1: Emergency Room
T2: 24h after trauma
T3: Discharge of hospital or 28 days after trauma

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Organizational Data

  •   DRKS00009559
  •   2015/10/27
  •   [---]*
  •   yes
  •   Approved
  •   346/14, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   TRAUMAINDIZIERTEKOAGULOPATHIE
  •   D65 -  Disseminated intravascular coagulation [defibrination syndrome]
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Interventions/Observational Groups

  •   Trauma patients which are rescued by the crew of the HEMS Christoph 22 (German Armed Forces Hospital Ulm, Germany) are included into the survey.
    At these patients two blood samples are taken via a peripheral vein. The first one on scene and the second one in the Emergency Department (Shock Trauma Room). Additionally several information about the prehospital as well as the inhospitable treatment are gathered. Finally all diagnosis are recorded.

    The total amount of the two blood samples is 16 milliliter.
    Parameters of special interest: Clotting-Time (CT), Clot-Formation-Time (CFT), Clot-Firmness (CF) A10 (Amplitude 10min past CT) and MCF (Maximum-Clot-Firmness) after 30min in EXTEM / FIBTEM of the thrombelastographie.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Do trauma patients with suspected / real blood loss and / or carciocirculatory instability have a TIC already in the prehospital setting (T0 = prehospital setting)?

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Secondary Outcome

Secondary Outcome:
Do patients with a proven TIC at T0 (longer CFT CFT, lower Clot firmness at T0) need more blood and blood products during their first 24h of treatment (T2 = 24h after injury)

Tertiary Outcome:
Do patients with a proven TIC at T0 (longer CFT CFT, lower Clot firmness at T0) have a higher 28 day mortality (T3 = 28 days after trauma)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/11/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with a sever mono trauma or a sever multi system trauma

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Exclusion Criteria

- sever hypothermia (< 30°C)
- pregnancy
- all types of coagulation inhibitors in patient history expect low dose aspirin
- hereditary or acquired coagulation deficits
- application of tranexamic acid before the blood sample (T0) could be obtained
- patient (or her / his custodian) do not agree to be part of this study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin
    • Mr.  Prof. Dr.  Matthias  Helm 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus UlmKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  Jürgen  Kerwchowski 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus UlmKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  PD Dr.  Martin  Kulla 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus Ulm
    • Ms.  Dr. med.  Ingeborg  Bretschneider 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin
    • Mr.  Prof. Dr.  Matthias  Helm 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Bretschneider I, Kerschowski J, Kulla M, Reger J, Schmid U, Allgöwer A, Hossfeld B, Helm M: Prähospitale Evaluation und Detektion der traumainduzierten Koagulopathie – PREDICT Zwischenauswertung (Abstract zu den Wissenschaftlichen Arbeitstagen Notfallmedizin (WATN) der Deutschen Gesellschaft für Anästhesie und Intensivmedizin (DGAI) am 5.2.2018 in Kiel, Deutschland). Anästh Intensivmed 59: S61-S62 (2018)
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* This entry means the parameter is not applicable or has not been set.