Traumatic Intracranial HemorrhageNCT06433622

Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)

An observational study of Traumatic Intracranial Hemorrhage, run by Lancaster General Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Traumatic Intracranial Hemorrhage
What is being tested?: Repeat Thromboelastography with Platelet Mapping
How many people: 225 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to Nov 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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

Study population: The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with TICH. Selection of subjects is based on all adult patients presenting with TICH that are admitted to Lancaster General Health Trauma Center.

Who may be able to join

Patients ≥ 18 years of age who present with TICH meeting Brain Injury Guidelines (BIG) 2 or 3 head bleed criteria
Currently on antiplatelet medication on admission
Must have taken this antiplatelet medication within the past 48 hours prior to presentation
Patients who have AA and/or ADP inhibition of 70% or greater and Maximum Amplitude (MA) <50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion
Patients with a TICH who are 18 years of age or older

Who cannot join

Under 18 years of age
Have a known bleeding diatheses
Current therapeutic anticoagulation use
Do not know the time of their last antiplatelet medication dose
Patients or their proxy who are unable to provide consent
Patients with concomitant long bone fractures or solid organ injuries
Abbreviated Injury Scale (AIS) >1 in body regions other than head because of concomitant long bone fracture or solid organ injury
Under 18 years of age

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17602

Other trials in United States

About this study

Official title: Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy

Read the detailed description

This study aims to determine if platelet function has improved following platelet transfusion by prospectively performing repeat thromboelastographic with platelet mapping (TEG-PM) assays on all patients consented and enrolled in the study. This study will also examine the rate of progression or stability of ICH on repeat head CT following platelet administration and will aid in the determination of a potential association between repeat CT head findings and the repeat TEG-PM results.

Conditions: Traumatic Intracranial Hemorrhage
Being tested: Repeat Thromboelastography with Platelet Mapping
Medical subject headings: Intracranial Hemorrhage, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repeat Thromboelastography with Platelet MappingDiagnostic test
Thromboelastography (TEG) is an assay used by many medical professionals to assess coagulopathy, predict outcomes, and guide treatment. Although TEG does not assess platelet function very well, a TEG with platelet mapping (TEG-PM) assay assesses platelet functioning by measuring the percent of arachidonic acid (AA) and adenosine diphosphate (ADP) that are inhibited in the patient's blood.

Study groups in NCT06433622
Study group	Role	What they receive
Repeat TEG-PM		Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria. Receives: Diagnostic Test: Repeat Thromboelastography with Platelet Mapping
No Repeat TEG-PM		Not eligible to be consented; will proceed with normal course of treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Repeat TEG
Rate of reversed pathway inhibition on repeat thromboelastography with platelet mapping (TEG-PM) when platelets are administered to TICH patients who are on antiplatelet therapy prior to admission.
Measured: 1 hour after platelets given
Repeat Head CT
Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan.
Measured: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.

Secondary outcomes (2)

Need for Neurosurgical Intervention
Determine the efficacy of platelet transfusion among this patient cohort by measuring need for neurosurgical intervention after second CT scan (ie: the failure of non-operative management)
Measured: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Discharge Status
Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status.
Measured: From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 2023Nov 2027

First posted30 May 2024
Study start1 Dec 2023
Primary completionDec 2026 (estimated)
Study completionNov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Traumatic Intracranial HemorrhageStudies 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: Case-control
Time perspective: Prospective
Enrolment: 225 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06433622
Sponsor's protocol ID: 2023-47
Status last verified: Oct 2025
First submitted: 30 Apr 2024
Last updated: 29 Oct 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016/S1474-4422(10)70069-7. No abstract available.
PubMed 20298955
Li L, Geraghty OC, Mehta Z, Rothwell PM; Oxford Vascular Study. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet. 2017 Jul 29;390(10093):490-499. doi: 10.1016/S0140-6736(17)30770-5. Epub 2017 Jun 13.
PubMed 28622955
Pace WD. Daily Low-Dose Aspirin, Diabetes, and Age-Still Looking for a Balance. JAMA Netw Open. 2021 Jun 1;4(6):e2112875. doi: 10.1001/jamanetworkopen.2021.12875. No abstract available.
PubMed 34152422
Alter SM, Mazer BA, Solano JJ, Shih RD, Hughes MJ, Clayton LM, Greaves SW, Trinh NQ, Hughes PG. Antiplatelet therapy is associated with a high rate of intracranial hemorrhage in patients with head injuries. Trauma Surg Acute Care Open. 2020 Nov 25;5(1):e000520. doi: 10.1136/tsaco-2020-000520. eCollection 2020.
PubMed 33294625
van den Brand CL, Tolido T, Rambach AH, Hunink MG, Patka P, Jellema K. Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage? J Neurotrauma. 2017 Jan 1;34(1):1-7. doi: 10.1089/neu.2015.4393. Epub 2016 May 9.
PubMed 26979949
Svedung Wettervik T, Lenell S, Enblad P, Lewen A. Pre-injury antithrombotic agents predict intracranial hemorrhagic progression, but not worse clinical outcome in severe traumatic brain injury. Acta Neurochir (Wien). 2021 May;163(5):1403-1413. doi: 10.1007/s00701-021-04816-0. Epub 2021 Mar 26.
PubMed 33770261
Peck KA, Calvo RY, Schechter MS, Sise CB, Kahl JE, Shackford MC, Shackford SR, Sise MJ, Blaskiewicz DJ. The impact of preinjury anticoagulants and prescription antiplatelet agents on outcomes in older patients with traumatic brain injury. J Trauma Acute Care Surg. 2014 Feb;76(2):431-6. doi: 10.1097/TA.0000000000000107.
PubMed 24458049
Fabbri A, Servadei F, Marchesini G, Bronzoni C, Montesi D, Arietta L; Societa Italiana di Medicina d'Emergenza Urgenza Study Group. Antiplatelet therapy and the outcome of subjects with intracranial injury: the Italian SIMEU study. Crit Care. 2013 Mar 21;17(2):R53. doi: 10.1186/cc12575.
PubMed 23514619
Joseph B, Pandit V, Aziz H, Kulvatunyou N, Hashmi A, Tang A, O'Keeffe T, Wynne J, Vercruysse G, Friese RS, Rhee P. Clinical outcomes in traumatic brain injury patients on preinjury clopidogrel: a prospective analysis. J Trauma Acute Care Surg. 2014 Mar;76(3):817-20. doi: 10.1097/TA.0b013e3182aafcf0.
PubMed 24553554
Van Ornam J, Pruitt P, Borczuk P. Is repeat head CT necessary in patients with mild traumatic intracranial hemorrhage. Am J Emerg Med. 2019 Sep;37(9):1694-1698. doi: 10.1016/j.ajem.2018.12.012. Epub 2018 Dec 10.
PubMed 30559018
Shammassian BH, Ronald A, Smith A, Sajatovic M, Mangat HS, Kelly ML. Viscoelastic Hemostatic Assays and Outcomes in Traumatic Brain Injury: A Systematic Literature Review. World Neurosurg. 2022 Mar;159:221-236.e4. doi: 10.1016/j.wneu.2021.10.180. Epub 2021 Nov 27.
PubMed 34844010
Fleming K, Redfern RE, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage. J Extra Corpor Technol. 2017 Dec;49(4):283-290.
PubMed 29302119
Fan D, Ouyang Z, Ying Y, Huang S, Tao P, Pan X, Lu S, Pan Q. Thromboelastography for the Prevention of Perioperative Venous Thromboembolism in Orthopedics. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221077975. doi: 10.1177/10760296221077975.
PubMed 35379018
Rao A, Lin A, Hilliard C, Fu R, Lennox T, Barbosa R, Schreiber M, Rowell S. The Utility of Thromboelastography for Predicting The Risk of Progression of Intracranial Hemorrhage in Traumatic Brain Injury Patients. Neurosurgery. 2017 Sep 1;64(CN_suppl_1):182-187. doi: 10.1093/neuros/nyx210. No abstract available.
PubMed 28899039
Kay AB, Morris DS, Collingridge DS, Majercik S. Platelet dysfunction on thromboelastogram is associated with severity of blunt traumatic brain injury. Am J Surg. 2019 Dec;218(6):1134-1137. doi: 10.1016/j.amjsurg.2019.09.024. Epub 2019 Sep 23.
PubMed 31575420

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Traumatic Intracranial Hemorrhage trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy
ClinicalTrials.gov ID: NCT06433622
Acronym / sponsor ID: 2023-47
Conditions: Traumatic Intracranial Hemorrhage
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 225 participants (estimated)
Lead sponsor: Lancaster General HospitalUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Nov 2027 (estimated)
First posted: 30 May 2024 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Repeat TEG-PM	–	Diagnostic Test: Repeat Thromboelastography with Platelet MappingWill receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.
No Repeat TEG-PM	–	–Not eligible to be consented; will proceed with normal course of treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with TICH. Selection of subjects is based on all adult patients presenting with TICH that are admitted to Lancaster General Health Trauma Center.

Key inclusion criteria (5 listed)

Patients ≥ 18 years of age who present with TICH meeting Brain Injury Guidelines (BIG) 2 or 3 head bleed criteria
Currently on antiplatelet medication on admission
Must have taken this antiplatelet medication within the past 48 hours prior to presentation
Patients who have AA and/or ADP inhibition of 70% or greater and Maximum Amplitude (MA) <50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion
Patients with a TICH who are 18 years of age or older

Key exclusion criteria (8 listed)

Under 18 years of age
Have a known bleeding diatheses
Current therapeutic anticoagulation use
Do not know the time of their last antiplatelet medication dose
Patients or their proxy who are unable to provide consent

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
Repeat Thromboelastography with Platelet MappingThromboelastography (TEG) is an assay used by many medical professionals to assess coagulopathy, predict outcomes, and guide treatment. Although TEG does not assess platelet function very well, a TEG with platelet mapping (TEG-PM) assay assesses platelet functioning by measuring the percent of arachidonic acid (AA) and adenosine diphosphate (ADP) that are inhibited in the patient's blood.	Diagnostic test	Repeat TEG-PM

Primary outcome

Repeat TEG
Time frame: 1 hour after platelets given
Rate of reversed pathway inhibition on repeat thromboelastography with platelet mapping (TEG-PM) when platelets are administered to TICH patients who are on antiplatelet therapy prior to admission.
Repeat Head CT
Time frame: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.
Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan.

2 secondary outcomes

Need for Neurosurgical Intervention
Time frame: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Discharge Status
Time frame: From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
Background: PubMed 20298955Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016/S1474-4422(10)70069-7. No abstract available.
Background: PubMed 28622955Li L, Geraghty OC, Mehta Z, Rothwell PM; Oxford Vascular Study. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet. 2017 Jul 29;390(10093):490-499. doi: 10.1016/S0140-6736(17)30770-5. Epub 2017 Jun 13.
Background: PubMed 34152422Pace WD. Daily Low-Dose Aspirin, Diabetes, and Age-Still Looking for a Balance. JAMA Netw Open. 2021 Jun 1;4(6):e2112875. doi: 10.1001/jamanetworkopen.2021.12875. No abstract available.
Background: PubMed 33294625Alter SM, Mazer BA, Solano JJ, Shih RD, Hughes MJ, Clayton LM, Greaves SW, Trinh NQ, Hughes PG. Antiplatelet therapy is associated with a high rate of intracranial hemorrhage in patients with head injuries. Trauma Surg Acute Care Open. 2020 Nov 25;5(1):e000520. doi: 10.1136/tsaco-2020-000520. eCollection 2020.
Background: PubMed 26979949van den Brand CL, Tolido T, Rambach AH, Hunink MG, Patka P, Jellema K. Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage? J Neurotrauma. 2017 Jan 1;34(1):1-7. doi: 10.1089/neu.2015.4393. Epub 2016 May 9.
Background: PubMed 33770261Svedung Wettervik T, Lenell S, Enblad P, Lewen A. Pre-injury antithrombotic agents predict intracranial hemorrhagic progression, but not worse clinical outcome in severe traumatic brain injury. Acta Neurochir (Wien). 2021 May;163(5):1403-1413. doi: 10.1007/s00701-021-04816-0. Epub 2021 Mar 26.
Background: PubMed 24458049Peck KA, Calvo RY, Schechter MS, Sise CB, Kahl JE, Shackford MC, Shackford SR, Sise MJ, Blaskiewicz DJ. The impact of preinjury anticoagulants and prescription antiplatelet agents on outcomes in older patients with traumatic brain injury. J Trauma Acute Care Surg. 2014 Feb;76(2):431-6. doi: 10.1097/TA.0000000000000107.
Background: PubMed 23514619Fabbri A, Servadei F, Marchesini G, Bronzoni C, Montesi D, Arietta L; Societa Italiana di Medicina d'Emergenza Urgenza Study Group. Antiplatelet therapy and the outcome of subjects with intracranial injury: the Italian SIMEU study. Crit Care. 2013 Mar 21;17(2):R53. doi: 10.1186/cc12575.
Background: PubMed 24553554Joseph B, Pandit V, Aziz H, Kulvatunyou N, Hashmi A, Tang A, O'Keeffe T, Wynne J, Vercruysse G, Friese RS, Rhee P. Clinical outcomes in traumatic brain injury patients on preinjury clopidogrel: a prospective analysis. J Trauma Acute Care Surg. 2014 Mar;76(3):817-20. doi: 10.1097/TA.0b013e3182aafcf0.
Background: PubMed 30559018Van Ornam J, Pruitt P, Borczuk P. Is repeat head CT necessary in patients with mild traumatic intracranial hemorrhage. Am J Emerg Med. 2019 Sep;37(9):1694-1698. doi: 10.1016/j.ajem.2018.12.012. Epub 2018 Dec 10.
Background: PubMed 34844010Shammassian BH, Ronald A, Smith A, Sajatovic M, Mangat HS, Kelly ML. Viscoelastic Hemostatic Assays and Outcomes in Traumatic Brain Injury: A Systematic Literature Review. World Neurosurg. 2022 Mar;159:221-236.e4. doi: 10.1016/j.wneu.2021.10.180. Epub 2021 Nov 27.
Background: PubMed 29302119Fleming K, Redfern RE, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage. J Extra Corpor Technol. 2017 Dec;49(4):283-290.
United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.Link provided by the sponsor.
Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Lindsey Perea, DO principal investigator

Penn Medicine Lancaster General Health

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 Traumatic Intracranial Hemorrhage, run by Lancaster General Hospital 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 5 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Repeat TEG (time frame: 1 hour after platelets given). 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?

On the ClinicalTrials.gov record for NCT06433622, which also lists 28 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 29 Oct 2025.