Traumatic Intracranial HaemorrhageOPTTICHNCT02260908
OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage - Pilot Study
A study testing Enoxaparin in people with Traumatic Intracranial Haemorrhage, run by McMaster University at 1 site in Canada.
Trial summary
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, resulting in death. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Intracranial Haemorrhage
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
Who cannot join
- Unexpected to survive or remain in hospital >72 hours
- Known malignancy under active care at time of admission
- Known DVT, PE or other condition requiring anticoagulation at time of admission
- 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
- Platelet count <75 x 10^9/L at 24 hours after admission
- Bilateral lower limb amputation
Show all 15Show fewer
- History of allergy to heparin or suspected or proven HIT
- Limitation of life support or palliative care
- Prior enrollment in this trial or currently in a confounding randomized trial
- Pregnancy
- Study drug (LMWH or placebo) not administered within 36-48 hours post-injury
- Grade V liver or splenic injuries that have not received definitive care (e.g. embolization, surgical intervention) within 36-48 hours after injury
- Persistent intracranial pressure >20 mm Hg
- Spinal subdural haematoma or spinal epidural haematoma
- Intracranial haemorrhage progression on 24-hour repeat CT scan
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences- General site
Hamilton, Ontario, L8L 2X2
Niv Sne, MD FRCSC, 905-527-4322 ext. 44665, nivsne@yahoo.ca
Niv Sne, MD FRCSC
About this study
Official title: OPTTICH Pilot Study - OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage
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, resulting in 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. In addition, 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 (36 to 48 hours after injury) versus the current practice (waiting until the 6th 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 OPTTICH (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.
- Conditions
- Traumatic Intracranial Haemorrhage
- Being tested
- Enoxaparin, Placebo
- Keywords
- Trauma, Thromboprophylaxis, Intracranial haemorrhage, Deep vein thrombosis
- Medical subject headings
- Intracranial Hemorrhage, Traumatic, Wounds and Injuries, Intracranial Hemorrhages, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Lovenox
Enoxaparin 30 mg subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.
PlaceboOther
0.9% normal saline in equal volume to active comparator given subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.
| Study group | Role | What they receive |
|---|---|---|
| Early initiation of thromboprophylaxis | Active comparator | Early initiation of thromboprophylaxis with Enoxaparin between 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6. Receives: Drug: Enoxaparin |
| Late initiation of thromboprophylaxis | Placebo comparator | Initiation of placebo (normal saline) 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
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 US will be recorded and stratified into above-knee (proximal DVT) or below-knee (distal DVT). Patients who have both proximal and distal DVT will be classified as having proximal DVT.
Measured: Maximum of 60 days or until hospital discharge.
Secondary outcomes (3)
Non-intracranial bleeding
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.
Measured: Maximum of 60 days or until hospital discharge.
Pulmonary Embolism (PE)
Patients who develop clinical suspicion 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 or the pulmonary artery. Patients with a high probability of PE on clinical grounds but with negative CT chest will undergo a ventilation-perfusion scan.
Measured: Maximum of 60 days or until hospital discharge.
Intracranial haemorrhage progression (IHP)
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.
Measured: Maximum of 60 days or until hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Intracranial HaemorrhageStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Niv Sne, McMaster University
- Investigators
- Niv Sne, MD FRCSC, Principal investigator, Hamilton Health Sciences/McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260908
- Sponsor's protocol ID
- OPT1-22-06-10
- Acronym
- OPTTICH
- Status last verified
- Apr 2015
- First submitted
- 6 Oct 2014
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTTICH Pilot Study - OPtimal Timing of Thromboprophylaxis in Traumatic IntraCranial Haemorrhage
- ClinicalTrials.gov ID
- NCT02260908
- Acronym / sponsor ID
- OPTTICH / OPT1-22-06-10
- Conditions
- Traumatic Intracranial Haemorrhage
- Keywords
- Trauma, Thromboprophylaxis, Intracranial haemorrhage, Deep vein thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, resulting in 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. In addition, 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 (36 to 48 hours after injury) versus the current practice (waiting until the 6th 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 OPTTICH (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early initiation of thromboprophylaxis | Active comparator | Drug: EnoxaparinEarly initiation of thromboprophylaxis with Enoxaparin between 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6. |
| Late initiation of thromboprophylaxis | Placebo comparator | Other: PlaceboInitiation of placebo (normal saline) 36-48 hours post-injury until day 5, followed by standard of care (DVT prophylaxis with Enoxaparin) starting on post-injury day 6. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Multi-system trauma patients referred to the trauma service with a non-progressing tICH documented on 24-hour repeat head CT scan
Key exclusion criteria (15 listed)
- Unexpected to survive or remain in hospital >72 hours
- Known malignancy under active care at time of admission
- Known DVT, PE or other condition requiring anticoagulation at time of admission
- 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
- Platelet count <75 x 10^9/L at 24 hours after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinAlso: LovenoxEnoxaparin 30 mg subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury. | Drug | Early initiation of thromboprophylaxis |
| Placebo0.9% normal saline in equal volume to active comparator given subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury. | Other | Late initiation of thromboprophylaxis |
Primary outcome
Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US).
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 US will be recorded and stratified into above-knee (proximal DVT) or below-knee (distal DVT). Patients who have both proximal and distal DVT will be classified as having proximal DVT.
3 secondary outcomes
Non-intracranial bleeding
Time frame: Maximum of 60 days or until hospital discharge.
Pulmonary Embolism (PE)
Time frame: Maximum of 60 days or until hospital discharge.
Intracranial haemorrhage progression (IHP)
Time frame: Maximum of 60 days or until hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niv Sne, MD FRCSC principal investigator
Hamilton Health Sciences/McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin in people with Traumatic Intracranial Haemorrhage, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niv Sne, MD FRCSC (905-527-4322 ext. 44665, nivsne@yahoo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal lower limb deep vein thrombosis (DVT) diagnosed by bilateral lower extremity compression ultrasound (US). (time frame: Maximum of 60 days or until hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.