Health Condition 1: S069- Unspecified intracranial injury
Conditions
Interventions
Intervention1: 1.inj Dalteparin
2.Sequential compression device.: This pragmatic RCT will directly compare the effectiveness and safety of two VTE
thromboprophylaxis strategies during the critical fir
Sponsors
Sunnybrook Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Patients with severe and moderate acute TBI defined as: a. GCS of =8 or b. GCS of 9-12 (moderate) with any intracranial hemorrhage seen on CT scan (patients with only subarachnoid hemorrhage are excluded) ii) Upon randomization patient can receive the first dose of study drug in the first 3 calendar days of the time of injury (within 72 hours after injury). ii) = 18 years of age
Exclusion criteria
Exclusion criteria: All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study: 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 ii) Known history of confirmed or suspected immunologically-mediated heparininduced 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. xii) Known Pregnancy xiii) Participants extremely low weight ( 120kg) xiv) Not expected to survive more than 48 hours from admission If it is determined after enrolment that if an enrolled patient had an exclusion criterion at the time of randomization which was not previously identified, the study drug will be discontinued. In these situations, the steering committee will review each case to determine whether the patient should also be excluded from the intention to treat analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symptomatic, objectively-confirmed PE. 2. Symptomatic, objectively-confirmed, proximal leg DVT. In this case, symptomatic would suggest that the patient has developed leg swelling or signs of venous stasis that can be directly attributed to a DVT during the first 7 study days, and this DVT would need to be objectively confirmed (for example using Doppler ultrasound). 3. Asymptomatic proximal leg DVT on Doppler ultrasound on Day 8-1 or +2 days (at Day 7, 8, 9 or 10) after Initiation of study drug. In this case, the DVT is detected during our routine screening on Day 8-1 or +2 days (at Day 7, 8, 9 or 10), and need not be associated with symptomsTimepoint: 30 days, 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes 1. Objectively confirmed new or progressing ICB on radiology assessed by comparing the baseline brain CT usually about 24 h after admission to that performed on Day 8 1 or 2 days at Day 7 8 9 or 10 or most recent prior to death This will be confirmed by volumetric measurements by a central neuroradiologist blinded to treatment allocation We have developed a protocol for quantitatively measuring changes in brain blood volume this approach has high interrater reliability Symptomatic VTE at Day 8 ie excluding those diagnosed based on radiology alone Any clinically important VTE occurring between Day 8 to Day 30 detected by treating clinicians Composite endpoint of either death or clinically important VTE at Day 8 after study drug initiation All mortalities at 8 days, 30 days & 180 days Glasgow Outcome Scale Extended GOSE at Day 30±5 and Day 180±14 by phone interview 7 EQ5D at Day 30±5 and Day 180±14 by phone interviewTimepoint: 30 days 180 days | — |
Countries
India
Contacts
Public ContactDr BK Misra
PD Hinduja Hospital, Mahim, Mumbai
Outcome results
None listed