Correcting Platelet Dysfunction After Traumatic Brain Injury

NCT ID: NCT03182946

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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

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Platelet Dysfunction Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Platelet mapping Thromboelastography

These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Platelet mitochondrial respiration Serum presence of microparticles Serum presence of cardiolipin Functional independence measure

Eligibility Criteria

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Inclusion Criteria

Traumatic brain injury with Glasgow Coma Scale Score (GCS) \<=13

Exclusion Criteria

Previously know coagulation dysfunction
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carolinas Medical Center

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Evans, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

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Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24368352 (View on PubMed)

Jokar 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.

Reference Type BACKGROUND
PMID: 27099065 (View on PubMed)

Ortiz 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.

Reference Type BACKGROUND
PMID: 22847399 (View on PubMed)

Nekludov 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.

Reference Type BACKGROUND
PMID: 18001200 (View on PubMed)

Hukkelhoven 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.

Reference Type BACKGROUND
PMID: 14567601 (View on PubMed)

Zharikov 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.

Reference Type BACKGROUND
PMID: 23356269 (View on PubMed)

Reddoch 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.

Reference Type BACKGROUND
PMID: 24169210 (View on PubMed)

Stiegler 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.

Reference Type BACKGROUND
PMID: 19175547 (View on PubMed)

Nair 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.

Reference Type BACKGROUND
PMID: 25159368 (View on PubMed)

Other Identifiers

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08-16-22E

Identifier Type: -

Identifier Source: org_study_id

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