Hyperfibrinolysis in moderate to severe traumatic brain injury-related coagulopathy

Hyperfibrinolysis in moderate to severe traumatic brain injury-related coagulopathy - LYSIS-TBI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37358

Enrollment

100

Registered

2012-08-01

Start date

2012-09-05

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Traumatisch schedelhersenletsel neurotrauma Traumatic Brain Injury (TBI)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Primary

Measure	Time frame
- 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	—

Countries

Netherlands

Outcome results