Platelet DysfunctionNCT03182946
Correcting Platelet Dysfunction After Traumatic Brain Injury
An observational study of Platelet Dysfunction and Traumatic Brain Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Platelet Dysfunction, Traumatic Brain Injury
- What is being tested?
- Platelet mapping Thromboelastography
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Jul 2021
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population will be geriatric patients with moderate to severe TBI (GCS <=13).
Who may be able to join
- Traumatic brain injury with Glasgow Coma Scale Score (GCS) <=13
Who cannot join
- Previously know coagulation dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28232
About this study
Official title: Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients
This study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.
Read the detailed description
The geriatric population is subject to traumatic brain injury, often occurring as a result of falls. This patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. Following Traumatic Brain Injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. Therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. Clinical practice at Carolinas Medical Center is to transfuse platelets in patients with platelet dysfunction following brain injury. The current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome.
Furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. Therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with Traumatic Brain Injury will be assessed.
- Conditions
- Platelet Dysfunction, Traumatic Brain Injury
- Being tested
- Platelet mapping Thromboelastography
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet mapping ThromboelastographyDiagnostic test
Also called Platelet mitochondrial respiration, Serum presence of microparticles, Serum presence of cardiolipin, Functional independence measure
These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet function
Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography
Measured: Within 5 hours
Secondary outcomes (2)
Mortality
Mortality will be compared to admission platelet inhibition
Measured: 1-3 months
Functional Independence Measure
Patient function as measured by Functional Independence Measure compared to platelet inhibition
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Oct 2017
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Platelet DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Carolinas Medical Center
- Responsible party
- Sponsor
- Investigators
- Susan Evans, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182946
- Sponsor's protocol ID
- 08-16-22E
- Status last verified
- Sep 2021
- First submitted
- 6 Jun 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only collaborators will have patient names for data acquisition.
Publications
Sillesen M, Rasmussen LS, Jin G, Jepsen CH, Imam A, Hwabejire JO, Halaweish I, DeMoya M, Velmahos G, Johansson PI, Alam HB. Assessment of coagulopathy, endothelial injury, and inflammation after traumatic brain injury and hemorrhage in a porcine model. J Trauma Acute Care Surg. 2014 Jan;76(1):12-9; discussion 19-20. doi: 10.1097/TA.0b013e3182aaa675.
PubMed 24368352Jokar TO, Khalil M, Rhee P, Kulvatunyou N, Pandit V, O'Keeffe T, Tang A, Joseph B. Ratio-based Resuscitation in Trauma Patients with Traumatic Brain Injury: Is There a Similar Effect? Am Surg. 2016 Mar;82(3):271-7.
PubMed 27099065Ortiz I, Velasco A, Le Borgne S, Revah S. Biodegradation of DDT by stimulation of indigenous microbial populations in soil with cosubstrates. Biodegradation. 2013 Apr;24(2):215-25. doi: 10.1007/s10532-012-9578-1. Epub 2012 Jul 31.
PubMed 22847399Nekludov M, Bellander BM, Blomback M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. doi: 10.1089/neu.2007.0322.
PubMed 18001200Hukkelhoven CW, Steyerberg EW, Rampen AJ, Farace E, Habbema JD, Marshall LF, Murray GD, Maas AI. Patient age and outcome following severe traumatic brain injury: an analysis of 5600 patients. J Neurosurg. 2003 Oct;99(4):666-73. doi: 10.3171/jns.2003.99.4.0666.
PubMed 14567601Zharikov S, Shiva S. Platelet mitochondrial function: from regulation of thrombosis to biomarker of disease. Biochem Soc Trans. 2013 Feb 1;41(1):118-23. doi: 10.1042/BST20120327.
PubMed 23356269Reddoch KM, Pidcoke HF, Montgomery RK, Fedyk CG, Aden JK, Ramasubramanian AK, Cap AP. Hemostatic function of apheresis platelets stored at 4 degrees C and 22 degrees C. Shock. 2014 May;41 Suppl 1(0 1):54-61. doi: 10.1097/SHK.0000000000000082.
PubMed 24169210Stiegler G, Fischer G, Ramanathan G, Bencur P, Weigel G, Mannhalter C. P-selectin mRNA is maintained in platelet concentrates stored at 4 degrees C. Transfusion. 2009 May;49(5):921-7. doi: 10.1111/j.1537-2995.2008.02073.x. Epub 2009 Jan 21.
PubMed 19175547Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.
PubMed 25159368
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients
- ClinicalTrials.gov ID
- NCT03182946
- Acronym / sponsor ID
- 08-16-22E
- Conditions
- Platelet Dysfunction, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Carolinas Medical Center
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Jun 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 evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.
Detailed description
The geriatric population is subject to traumatic brain injury, often occurring as a result of falls. This patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. Following Traumatic Brain Injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. Therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. Clinical practice at Carolinas Medical Center is to transfuse platelets in patients with platelet dysfunction following brain injury. The current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome.
Furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. Therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with Traumatic Brain Injury will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be geriatric patients with moderate to severe TBI (GCS <=13).
Key inclusion criteria (1 listed)
- Traumatic brain injury with Glasgow Coma Scale Score (GCS) <=13
Key exclusion criteria (1 listed)
- Previously know coagulation dysfunction
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 |
|---|---|---|
| Platelet mapping ThromboelastographyAlso: Platelet mitochondrial respiration, Serum presence of microparticles, Serum presence of cardiolipin, Functional independence measureThese diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome. | Diagnostic test | – |
Primary outcome
Change in platelet function
Time frame: Within 5 hours
Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography
2 secondary outcomes
Mortality
Time frame: 1-3 months
Functional Independence Measure
Time frame: 6-12 months
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 21 Apr 2022.
- Background: PubMed 24368352Sillesen M, Rasmussen LS, Jin G, Jepsen CH, Imam A, Hwabejire JO, Halaweish I, DeMoya M, Velmahos G, Johansson PI, Alam HB. Assessment of coagulopathy, endothelial injury, and inflammation after traumatic brain injury and hemorrhage in a porcine model. J Trauma Acute Care Surg. 2014 Jan;76(1):12-9; discussion 19-20. doi: 10.1097/TA.0b013e3182aaa675.
- Background: PubMed 27099065Jokar TO, Khalil M, Rhee P, Kulvatunyou N, Pandit V, O'Keeffe T, Tang A, Joseph B. Ratio-based Resuscitation in Trauma Patients with Traumatic Brain Injury: Is There a Similar Effect? Am Surg. 2016 Mar;82(3):271-7.
- Background: PubMed 22847399Ortiz I, Velasco A, Le Borgne S, Revah S. Biodegradation of DDT by stimulation of indigenous microbial populations in soil with cosubstrates. Biodegradation. 2013 Apr;24(2):215-25. doi: 10.1007/s10532-012-9578-1. Epub 2012 Jul 31.
- Background: PubMed 18001200Nekludov M, Bellander BM, Blomback M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. doi: 10.1089/neu.2007.0322.
- Background: PubMed 14567601Hukkelhoven CW, Steyerberg EW, Rampen AJ, Farace E, Habbema JD, Marshall LF, Murray GD, Maas AI. Patient age and outcome following severe traumatic brain injury: an analysis of 5600 patients. J Neurosurg. 2003 Oct;99(4):666-73. doi: 10.3171/jns.2003.99.4.0666.
- Background: PubMed 23356269Zharikov S, Shiva S. Platelet mitochondrial function: from regulation of thrombosis to biomarker of disease. Biochem Soc Trans. 2013 Feb 1;41(1):118-23. doi: 10.1042/BST20120327.
- Background: PubMed 24169210Reddoch KM, Pidcoke HF, Montgomery RK, Fedyk CG, Aden JK, Ramasubramanian AK, Cap AP. Hemostatic function of apheresis platelets stored at 4 degrees C and 22 degrees C. Shock. 2014 May;41 Suppl 1(0 1):54-61. doi: 10.1097/SHK.0000000000000082.
- Background: PubMed 19175547Stiegler G, Fischer G, Ramanathan G, Bencur P, Weigel G, Mannhalter C. P-selectin mRNA is maintained in platelet concentrates stored at 4 degrees C. Transfusion. 2009 May;49(5):921-7. doi: 10.1111/j.1537-2995.2008.02073.x. Epub 2009 Jan 21.
- Background: PubMed 25159368Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.
- Individual participant dataSharing planned: No. Only collaborators will have patient names for data acquisition.
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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.
Susan Evans, MD principal investigator
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Dysfunction and Traumatic Brain Injury, run by Wake Forest University Health Sciences 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 1 inclusion and 1 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 21 Apr 2022. 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?
Change in platelet function (time frame: Within 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182946, which also lists 9 linked publications.
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 21 Apr 2022.