D65.1
Conditions
Interventions
Group 1: Material:
- Sodium citrate blood of the trauma patient, which is taken once preclinical and once in-hospital in the emergency department. The sample containers are citrate-coated Monovettes f
Sponsors
Bundesministerium für Verteidigung / Sanitätsakademie der Bundeswehr / Wehrmedizinische Sonderforschung / Abteilung EProjekt ID:
Eligibility
Sex/Gender
All
Age
18 Years to 130 Years
Inclusion criteria
Inclusion criteria: inclusion criteria (AND) - Trauma history and - Patient age >= 18 years - actual or suspected acute bleeding situation and / or existing circulatory instability
Exclusion criteria
Exclusion criteria: Exclusion criteria (OR) - severe hypothermia <30 ° C possibly subsequent exclusion - pregnant patients - Anticoagulated patients (vitamin K antagonists, NOAKs and other) except ASS or clopidogrel. - pre-existing acquired or hereditary thrombophilia or coagulopathy - Tranexamic acid administration before prehospital blood sampling - Refusal of the patient to participate in clinical trials A subsequent exclusion takes place in the event of later disclosure of the existence of exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal is to check a threshold value of -6mmol/L for the detection of early trauma-induced coagulopathy in the trauma patient with actual or suspected bleeding and / or existing circulatory instability (time T0 = emergency department and T1 = emergency room) Target parameters: Preclinical and in-clinic BaseExcess, Clotting Time (CT) lengthened, Clot Formation Time (CFT) extended, Clot Firmness (CF) A10 (Amplitude 10 min after CT) and MCF (Maximum Clot Firmness) after 30 min decreases in EXTEM and FIBTEM of thrombelastometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary goal is to examine a possible thrombocytic involvement in the development of early stage TIC by measuring platelet function on the rotemplatelet and measuring platelet counts. The tertiary goal is to demonstrate increased transfusion and coagulation substitution needs in the first 24 hours (T2 time) at decreased BE beyond the assumed limit, with simultaneously prolonged CT, CFT and reduced clot strength, thus demonstrating early TIC as well as the survey mortality after 28 days and review of a possible correlation of mortality and trauma-induced coagulopathy (time T3). Hypothesis: A threshold value of the base excess (BE) of -6mmol/L can be assumed as the early detection parameter of TIC in severe trauma with suspected relevant blood loss and / or circulatory instability. Target parameters: Preclinical and in-clinic BaseExcess, Clotting Time (CT) lengthened, Clot Formation Time (CFT) extended, Clot Firmness (CF) A10 (Amplitude 10 min after CT) and MCF (Maximum Clot Firmness) after 30 min decreases in EXTEM and FIBTEM of thrombelastometry. Examination dates: T0: out of hospital phase (beginning) T1: Emergency Room (beginning) T2: 24 hours after trauma T3: hospital discharge or 28 days after trauma in the clinic | — |
Countries
Germany
Contacts
Public ContactJürgen Kerschowski
Bundeswehrkrankenhaus Ulm / Klinik für Anästhesie und Intensivmedizin
Outcome results
None listed