OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage (OPTTTICH Study) (OPTTTICH)
|ClinicalTrials.gov Identifier: NCT01589393|
Recruitment Status : Unknown
Verified April 2012 by Niv Sne, McMaster University.
Recruitment status was: Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : May 9, 2012
|Condition or disease||Intervention/treatment|
|Traumatic Intracranial Haemorrhage||Drug: Enoxaparin Other: Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage (OPTTTICH Study)|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||September 2012|
Active Comparator: Early initiation of thromboprophylaxis
Early initiation of thromboprophylaxis with Enoxaparin between 36-48 hours post injury to day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting day 6 post injury.
Enoxaparin 30 mg subcutaneously twice daily for six doses starting 36-48 hours post traumatic injury.
Other Name: Lovenox
Placebo Comparator: Late initiation of thromboprophylaxis
Initiation of placebo 36-48 hours post traumatic injury until day 5, then standard of care (DVT prophylaxis with Enoxaparin) starting on Day 6.
0.9% normal saline in equal volume to active comparator given subcutaneously twice daily starting 36-48 hours post traumatic injury for six doses.
- Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound. [ Time Frame: Maximum of 60 days or until hospital discharge. ]Ultrasounds will be performed within 72 hours of enrollment as well as twice weekly when in ICU and weekly thereafter. Non-compressibility of 1 or more proximal deep venous segments on compression US will be considered diagnostic. Each segment will be assessed as fully compressible, partially compressible, not compressible, or not well visualized. All positive ultrasounds will be recorded and stratified into above knee (proximal DVT) or below knee (distal DVT). Patients who have both proximal and distal vein thrombus will be classified as having proximal DVT.
- Non-intracranial bleeding [ Time Frame: Maximum of 60 days or until hospital discharge. ]Non-intracranial bleeding events will be recorded and classified as either major or minor bleeding, according to a modified bleeding assessment tool adapted to our patient population.
- Pulmonary Embolism [ Time Frame: Maximum of 60 days or until hospital discharge ]Patients who develop clinical suspsicion of PE will have a helical CT chest. Pulmonary embolism will be diagnosed by the presence of an intraluminal filling defect detected in either the main,lobar,or segmental branches of the pulmonary artery. Patients with a high probability of PE on clinical grounds but with negative CT chest will undergo a ventilation-perfusion scan.
- Intracranial haemorrhage progression (IHP). [ Time Frame: Maximum of 60 days or until hospital discharge. ]If a Patient develops clinical evidence of neurological deterioration an emergent head CT scan will be performed.The CT scan will be reviewed by the blinded attending neuroradiologist. A comparison to the previous CT scan will be made and assessed for evidence of IHP. Intracranial haemorrhage progression will be defined as either 1) the development of a new haematoma, 2) any enlargement of an existing haematoma by an attending neuroradiologist's CT report, or 3) any progression of haematoma by the Marshall Head CT Classification System.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589393
|Hamilton Health Sciences- General site|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Niv Sne, MD FRCSC||Hamiltn Health Sciences/McMaster University|