Aspirin TreatmentPhase 2NCT01135862
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
A Phase 2 study testing platelets in people with Aspirin Treatment and Traumatic Intracranial Bleed, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspirin Treatment, Traumatic Intracranial Bleed, Hemorrhage Growth
- What is being tested?
- platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jun 2013
- Phase
- Phase 2
- 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
- age >18 years old
- chronic aspirin treatment
- first CT scan less than 12 hours following the trauma
- GCS >3
- no immediate surgical cranial lesion
- isolated head injury
- consent
- contusions >1.5cc or acute subdural hemorrhage in any size
Who cannot join
- anticoagulation treatment
- more than one antiaggregate
- coagulopathy
- thrombocytopenia (less than 100000)
- intracranial tumor
- active hematological disease
- more than 8 hours between first and second CT scan
- more than 2 hours between first CT and platelet admission
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv
Jonathan Roth, MD, 972-524262095, jonaroth@gmail.com
About this study
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
Read more
In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
Read the detailed description
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
- Being tested
- platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plateletsDrug
6 packs of platelets will be administered
| Study group | Role | What they receive |
|---|---|---|
| platelet administered | Experimental | patients will receive 6 packs of platelets Receives: Drug: platelets |
| no platelets administered | No intervention | patients will not receive platelets Receives: Drug: platelets |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
Measured: 6 hours
are lower aspirin doses a risk for early hemorrhagic growth
Measured: 6 hours
Secondary outcomes (3)
vascular complications
vascular complications include active ischemic heart disease (MI, unstable angina), ischemic stroke, acute peripheral vasculopathy, deep vein thrombosis, and pulmonary emboli these complications will be diagnosed clinically and not by screening procedures.
Measured: within 1 month from platelet admission
complications attributed to platelets as listed below
these complications include an exacerbation of congestive heart failure, or any allergic reaction to platelet admission such as fever, rigor, rash, hemodynamic collapse occuring within 6 hours of platelet admission.
other events which will be attributed to platelet admission are sepsis <48 hours after platelet admission or new thrombocytopenia occurring within 1 week after admission of platelets.
Measured: within 1 week
difference in neurological outcome between both groups
as evaluated by Glasgow Outcome Score (GOS)
Measured: 1 month, 6 months, and 1 year after the traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin TreatmentStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Jonathan Roth, MD, Principal investigator, Tel-Aviv Sorasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135862
- Sponsor's protocol ID
- CTIL-000-JR-08-TASMC
- Status last verified
- Jun 2010
- First submitted
- 8 Mar 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
- ClinicalTrials.gov ID
- NCT01135862
- Acronym / sponsor ID
- CTIL-000-JR-08-TASMC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 3 Jun 2010 (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.
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
Detailed description
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones).
Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed.
In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets.
The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet administered | Experimental | Drug: plateletspatients will receive 6 packs of platelets |
| no platelets administered | No intervention | Drug: plateletspatients will not receive platelets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >18 years old
- chronic aspirin treatment
- first CT scan less than 12 hours following the trauma
- GCS >3
- no immediate surgical cranial lesion
Key exclusion criteria (8 listed)
- anticoagulation treatment
- more than one antiaggregate
- coagulopathy
- thrombocytopenia (less than 100000)
- intracranial tumor
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 |
|---|---|---|
| platelets6 packs of platelets will be administered | Drug | no platelets administered, platelet administered |
Primary outcome
efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
Time frame: 6 hours
are lower aspirin doses a risk for early hemorrhagic growth
Time frame: 6 hours
3 secondary outcomes
vascular complications
Time frame: within 1 month from platelet admission
complications attributed to platelets as listed below
Time frame: within 1 week
difference in neurological outcome between both groups
Time frame: 1 month, 6 months, and 1 year after the traumatic brain injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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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.
Jonathan Roth, MD principal investigator
Tel-Aviv Sorasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing platelets in people with Aspirin Treatment and Traumatic Intracranial Bleed, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 8 inclusion and 8 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 3 Jun 2010. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jonathan Roth (972-524262095, jonaroth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 3 Jun 2010.