TBI (Traumatic Brain Injury)Phase 4NCT03081169
Timing of VTE Prophylaxis in TBI
A Phase 4 study testing Enoxaparin Sodium 150 MG/ML Prefilled Syringe and Heparin in people with TBI (Traumatic Brain Injury) and VTE (Venous Thromboembolism), run by Loyola University at 1 site in United States.
Trial summary
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury), VTE (Venous Thromboembolism)
- What is being tested?
- Enoxaparin Sodium 150 MG/ML Prefilled Syringe and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 12 Aug 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic brain injury
- Intracranial hemorrhage on CT scan
Who cannot join
- Under the age of 18
- Pregnant
- Die within 24 hours of admission
- Hospital stay less than 5 days
- Contraindications to enoxaparin or heparin
- Coagulopathy at 24 hours post-injury defined as INR>1.6 aPTT>2x normal, or platelet counts<50k
- Known history of VTE
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.
Read the detailed description
This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.
- Being tested
- Enoxaparin Sodium 150 MG/ML Prefilled Syringe, Heparin
- Medical subject headings
- Brain Injuries, Traumatic, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Sodium 150 MG/ML Prefilled SyringeDrug
Also called Lovenox
The same drugs and dosages will be used in both groups, with only the timing being different
HeparinDrug
The same drugs and dosages will be used in both groups, with only the timing being different
| Study group | Role | What they receive |
|---|---|---|
| Early (24 hours) | Active comparator | Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable. Receives: Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe; Drug: Heparin |
| Late (72 hours) | Active comparator | Patients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable. Receives: Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe; Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE
Rate of venous thromboembolism (DVT or PE)
Measured: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Secondary outcomes (1)
Bleeding complications
Rate of expanding intracranial hemorrhage
Measured: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start3 Apr 2017
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: Recruitment not started due to potential conflicting study at same institution. May renew study in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Anstadt, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081169
- Sponsor's protocol ID
- 209199
- Status last verified
- Aug 2019
- First submitted
- 25 Jan 2017
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03081169
- Acronym / sponsor ID
- 209199
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment not started due to potential conflicting study at same institution. May renew study in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 16 Mar 2017 (actual)
- 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.
This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.
Detailed description
This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early (24 hours) | Active comparator | Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe, Drug: HeparinPatients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 24 hours after injury if CT head is stable. |
| Late (72 hours) | Active comparator | Drug: Enoxaparin Sodium 150 MG/ML Prefilled Syringe, Drug: HeparinPatients will receive VTE prophylaxis (heparin 5000 U q 8 hrs or enoxaparin 30 mg q 12 hrs) 72 hours after injury if CT head is stable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Traumatic brain injury
- Intracranial hemorrhage on CT scan
Key exclusion criteria (7 listed)
- Under the age of 18
- Pregnant
- Die within 24 hours of admission
- Hospital stay less than 5 days
- Contraindications to enoxaparin or heparin
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 |
|---|---|---|
| Enoxaparin Sodium 150 MG/ML Prefilled SyringeAlso: LovenoxThe same drugs and dosages will be used in both groups, with only the timing being different | Drug | Early (24 hours), Late (72 hours) |
| HeparinThe same drugs and dosages will be used in both groups, with only the timing being different | Drug | Early (24 hours), Late (72 hours) |
Primary outcome
VTE
Time frame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Rate of venous thromboembolism (DVT or PE)
1 secondary outcome
Bleeding complications
Time frame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for TBI (Traumatic Brain Injury)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin Sodium 150 MG/ML Prefilled Syringe and Heparin in people with TBI (Traumatic Brain Injury) and VTE (Venous Thromboembolism), run by Loyola University at 1 site in United States.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 16 Aug 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE (time frame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.). 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 16 Aug 2019.