This study aims to gain insight in the in the level of fibrinolysis in patients with traumatic brain injury in the first 24 hours following trauma.Primairy objective:- To determine the 24-hour prevalence and course of fibrinolysis in patients with…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
Traumatisch schedelhersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Level of fibrinolysis using rotation thromboelastometry (ROTEM)
- DIC using ISTH DIC scoring system (platelet count, D-dimer, prolonged PT and
fibrinogen level)
- Tissue hemoglobin oxygenation using near infrared spectroscopy (NIRS)
- Endothelial barrier function will be analyzed in an Electric Cell-Substrate
Impedance Sensing (ECIS) system
Secondary outcome
Classical coagulation tests
- Activated partial thromboplastin time (aPTT)
- Hematocrit (Ht), hemoglobin (Hb)
Plasma coagulation parameters:
- Plasma tissue factor antigen
- Fibrin formation
- Thrombin-antithrombin III complex
- D-dimers and E-fragments (fibrin degradation products)
- Activated protein C-protein C inhibitor complex
- Plasminogen activator inhibitor-1 (PAI-1)
- Tissue plasminogen activator (t-PA)
- Thrombin activatable fibrinolysis inhibitor (TAFI)
- Thrombomodulin and thrombin/thrombomodulin complex
Coagulation parameters will be associated with patient demographics,
prehospital treatment characteristics, surgical and pharmacological
interventions, base deficit (BD), arterial oxygen pressure (pO2), arterial
carbon dioxide pressure (pCO2), lactate, pH, fluid management, use of
anticoagulants, alcohol abuse, cranial CT scan classification, GCS at the
accident scene and upon hospital admission, Revised Trauma Score (RTS)
Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), 6-month neurologic
and overall patient outcome (Glasgow Outcome Scale (GOS), and 6-month
mortality).
Background summary
Traumatic brain injury (TBI) accounts for a significant proportion of death and
disabilities worldwide. The development of coagulation abnormalities in TBI is
a complex and serious systemic disorder, which can be characterized by a
combination of coagulopathy and hypercoagulability. However, until now,
evidence-based diagnostic and treatment strategies for coagulopathy in TBI are
lacking.
Study objective
This study aims to gain insight in the in the level of fibrinolysis in patients
with traumatic brain injury in the first 24 hours following trauma.
Primairy objective:
- To determine the 24-hour prevalence and course of fibrinolysis in patients
with moderate to severe TBI who are admitted to the emergency department (ED)
of the VU University Medical Center.
- To determine the relation of these hemostatic abnormalities with regional
tissue perfusion.
Secondary objectives
- To determine development of coagulopathy and the association with specific
patterns in activated protein C, PAI-1 and TAFI levels.
- To determine the relation of early and delayed coagulopathy with the presence
of procoagulant and anticoagulant factors in plasma in moderate to severe TBI.
- To establish the effect of plasma from TBI patients with or without
coagulopathy on endothelial barrier function.
Study design
Prospective, observational study in 100 patients with moderate to severe TBI.
Study burden and risks
The burden associated with participation consists of extra blood sampling (3 x
14 ml) from an existing intravenous line and non-invasive tissue oxygenation
measurements. Both measurements are associated with a minimal risk and burden
for the patients.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Patients with moderate to severe traumatic brain injury
- Glasgow Coma Scale (GCS) score between 3 and 13 upon ED admission
- Age 18-75 years
Exclusion criteria
- Patients with hemostatic deficiencies or previous hemostatic problems
- Prehospital traumatic cardiopulmonary resuscitation
- Emergency surgery in the hour following ED admission
- Absence of a peripheral intravenous catheter
- Patients using vitamin K antagonists, clopidogrel or dabigatran
- Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39832.029.12 |