Correcting Platelet Dysfunction After Traumatic Brain Injury

NCT03182946 | Completed DMC

• 1 other identifier: 08-16-22E
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Dysfunction; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in platelet function

  Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography

  Within 5 hours

Secondary Outcomes (2)

• Mortality

  1-3 months

• Functional Independence Measure

  6-12 months

Interventions

Platelet mapping Thromboelastography DIAGNOSTIC_TEST

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

Also known as: Platelet mitochondrial respiration, Serum presence of microparticles, Serum presence of cardiolipin, Functional independence measure

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population will be geriatric patients with moderate to severe TBI (GCS \<=13).

You may qualify if:

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

You may not qualify if:

• Previously know coagulation dysfunction

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Carolinas Medical Center: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

Related Publications (9)

• 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.

  PMID: 24368352 BACKGROUND

• 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.

  PMID: 27099065 BACKGROUND

• 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.

  PMID: 22847399 BACKGROUND

• 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.

  PMID: 18001200 BACKGROUND

• 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.

  PMID: 14567601 BACKGROUND

• 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.

  PMID: 23356269 BACKGROUND

• 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.

  PMID: 24169210 BACKGROUND

• 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.

  PMID: 19175547 BACKGROUND

• 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.

  PMID: 25159368 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from which platelet function and platelet mitochondrial function will be analyzed, as well as serum markers for mitochondrial function

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Susan Evans, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 21, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)