Testing Dalteparin against a placebo for traumatic brain injury

Inclusion

• +ii) Patients with moderate TBI defined as GCS = 9-12, admitted to ICU, with at least some ICB present on initial CT scan and any of the following:
• +i) Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products
• +The pragmatic nature of this study seeks to include all consecutive patients presenting with significant TBI, regardless of whether ICB is evident at presentation. Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → are the following:
• +i) Patients with severe TBI defined as GCS of ≤8, or
• +Requiring invasive mechanical ventilation at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• +Increased ICB on repeat CT scan compared to initial CT scan
• +iii) Upon randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → the patient will be able to receive the first dose of study drug in the first 3 calendar days from the time of injury
• +iv) ≥ 18 years of age
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +All participants meeting any of the following exclusion criteria at baselineBaselineYour starting measurements, taken before treatment begins.Read more → will be excluded from participation in this study:
• +ii) Known history of confirmed or suspected immunologically-mediated heparin-induced thrombocytopenia (delayed-onset severe thrombocytopenia), and/or in patients with a known history of a positive in vitro platelet-aggregation test in the presence of FRAGMIN (Dalteparin) is positive
• +iii) Known septic endocarditis
• +iv) Uncontrollable active bleeding
• +v) Known major blood clotting disorders
• +vi) Known acute gastroduodenal ulcer (with active bleeding)
• +vii) Severe uncontrolled hypertension (i.e. BP\>210 despite medications)
• +viii) Known diabetic or hemorrhagic retinopathy
• +ix) Anticipated to be unable to receive SCD on at least one lower extremity due to nature of injuries for duration of intervention period
• +x) Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure)
• +xi) Known presence of irreversible coagulopathies
• +xiii) Participants extremely low weight (\<45 kg), or extremely high weight (\>120kg)
• +xiv) Not expected to survive more than 48 hours from admission
• +xii) Known Pregnancy