Head Injury Trauma BluntASA/PlavixNCT01534117
Platelet Function Analysis in Head Trauma: ASA/Plavix
A study testing Platelets and DDAVP in people with Head Injury Trauma Blunt, run by Chang, Steve S., M.D. at 1 site in United States.
Trial summary
The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Injury Trauma Blunt
- What is being tested?
- Platelets and DDAVP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18yrs
- Must be a trauma patient with blunt head trauma.
- Must be on Aspirin and/or Plavix
- Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).
Who cannot join
- Hemoglobin ≤ 10 GM/DL
- Platelet Count ≤ 150 K/MCL
- Pregnant Females
- Subjects on Warfarin, Heparin or Enoxaparin
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
About this study
Official title: Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL
The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.
Read the detailed description
The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:
Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.
- Conditions
- Head Injury Trauma Blunt
- Being tested
- Platelets, DDAVP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlateletsBiological
1 unit of platelets
DDAVPDrug
Desmopressin 0.3mcg/kg IV x 1
| Study group | Role | What they receive |
|---|---|---|
| Platelets/DDAVP | Active comparator | Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP Receives: Biological: Platelets; Drug: DDAVP |
| No Platelets | No intervention | Those that sustain head trauma NOT requiring platelet transfusion. The investigators are evaluating platelet function in those not requiring platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet inhibition
We are measuring platelet inhibition using the verify now platelet function analyzer
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury Trauma BluntStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang, Steve S., M.D.
- Collaborators
- Santa Barbara Cottage Hospital, Accumetrics, Inc.
- Responsible party
- Sponsor
- Investigators
- Steve S Chang, MD, Principal investigator, Santa Barbara Cottage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534117
- Sponsor's protocol ID
- ASA/Plavix/Platelets_SBCH
- Acronym
- ASA/Plavix
- Status last verified
- Feb 2012
- First submitted
- 8 Feb 2012
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL
- ClinicalTrials.gov ID
- NCT01534117
- Acronym / sponsor ID
- ASA/Plavix / ASA/Plavix/Platelets_SBCH
- Conditions
- Head Injury Trauma Blunt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Chang, Steve S., M.D.
- Collaborators
- Santa Barbara Cottage Hospital, Accumetrics, Inc.
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Feb 2012 (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.
The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.
Detailed description
The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:
Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelets/DDAVP | Active comparator | Biological: Platelets, Drug: DDAVPFall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP |
| No Platelets | No intervention | –Those that sustain head trauma NOT requiring platelet transfusion. The investigators are evaluating platelet function in those not requiring platelet transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18yrs
- Must be a trauma patient with blunt head trauma.
- Must be on Aspirin and/or Plavix
- Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).
Key exclusion criteria (4 listed)
- Hemoglobin ≤ 10 GM/DL
- Platelet Count ≤ 150 K/MCL
- Pregnant Females
- Subjects on Warfarin, Heparin or Enoxaparin
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 |
|---|---|---|
| Platelets1 unit of platelets | Biological | Platelets/DDAVP |
| DDAVPDesmopressin 0.3mcg/kg IV x 1 | Drug | Platelets/DDAVP |
Primary outcome
Platelet inhibition
Time frame: 8 hours
We are measuring platelet inhibition using the verify now platelet function analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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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.
Steve S Chang, MD principal investigator
Santa Barbara Cottage Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelets and DDAVP in people with Head Injury Trauma Blunt, run by Chang, Steve S., M.D. 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 Feb 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Platelet inhibition (time frame: 8 hours). 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 Feb 2012.