OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage (OPTTTICH Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by McMaster University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Niv Sne, McMaster University
ClinicalTrials.gov Identifier:
NCT01589393
First received: April 26, 2012
Last updated: May 8, 2012
Last verified: April 2012
  Purpose

Victims of trauma with severe head injury who have bled into their brains are at high risk of developing blood clots in their legs. These blood clots can break off and travel through the bloodstream to the lungs causing death. Blood thinners can be given to patients to prevent blood clots from developing but this can leave patients at risk for additional bleeding in the brain causing further damage or death. The earlier blood thinners are started the more effective they are at preventing blood clots but some patients with severe head injury who have bled into their brains will develop further bleeding even if they do not receive blood thinners. Even though a growing body of research has shown that the majority of bleeding in the brain stops within the first 24 hours after injury and that it is safe to start blood thinners as early as 24 hours after injury, doctors are still waiting longer than 4 days to start blood thinners in these patients over concerns of worsening bleeding. In Canada, almost half of the patients with severe head injury do not receive blood thinners until at least five days after injury. Delays in starting blood thinners appear to put patients at increased risk of developing blood clots, unnecessarily. This study will compare the benefits of starting low-molecular weight heparin (LMWH), a type of blood thinner, early (less than 48 hours) versus the current practice (waiting until the 5th day after being injured) in preventing blood clots in patients who have bled into their brains after severe head injury. The investigators believe that starting LMWH earlier will be more effective in preventing blood clots without worsening any bleeding when compared to waiting to start blood thinners. This study is called OPTTTICH (Optimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage) and will be the largest Canadian investigator-initiated randomized control trial on blood clot prevention in trauma patients with severe head injury who have bled into their brains.


Condition Intervention
Traumatic Intracranial Haemorrhage
Drug: Enoxaparin
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage (OPTTTICH Study)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound. [ Time Frame: Maximum of 60 days or until hospital discharge. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Non-intracranial bleeding [ Time Frame: Maximum of 60 days or until hospital discharge. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Enoxaparin
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.
Other: Placebo
0.9% normal saline in equal volume to active comparator given subcutaneously twice daily starting 36-48 hours post traumatic injury for six doses.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan

Exclusion Criteria:

  1. Less than 16 years of age
  2. Unexpected to survive or to remain in hospital >72 hours
  3. Known malignancy under active care at time of admission
  4. Known DVT, PE, or other condition requiring anticoagulation at time of admission
  5. Coagulopathy (defined as international normalized ratio (INR) values >1.5 times the upper limit of normal, or partial thromboplastin time (PTT) values >1.5 times the upper limit of normal) at 24 hours after admission
  6. Platelet count <75 x 109/L at 24 hours after admission
  7. Bilateral lower limb amputation
  8. History of allergy to heparin or suspected or proven HIT
  9. Limitation of life support or palliative care
  10. Prior enrolment in this trial or currently in a confounding randomized trial
  11. Pregnancy
  12. Study drug (LMWH or placebo) not administered within 36-48 hours post-injury
  13. Grade V liver or splenic injuries that have not received definitive care (e.g. embolization, surgical intervention) within 36-48 hours after injury
  14. Persistent intracranial pressure >20 mm Hg
  15. Spinal subdural haematoma or spinal epidural haematoma
  16. Intracranial haemorrhage progression on 24-hour repeat CT head scan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589393

Locations
Canada, Ontario
Hamilton Health Sciences- General site
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Niv Sne, MD FRCSC Hamiltn Health Sciences/McMaster University
  More Information

No publications provided

Responsible Party: Niv Sne, Dr. Niv Sne, Director of trauma research, McMaster University
ClinicalTrials.gov Identifier: NCT01589393     History of Changes
Other Study ID Numbers: CIHR-2009
Study First Received: April 26, 2012
Last Updated: May 8, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Trauma
Thromboprophylaxis
Intracranial haemorrhage
Deep vein Thrombosis

Additional relevant MeSH terms:
Hemorrhage
Intracranial Hemorrhages
Intracranial Hemorrhage, Traumatic
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014