Correcting Platelet Dysfunction After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182946
• Other study ID #: 08-16-22E
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Previously know coagulation dysfunction

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Brain Injuries
• Brain Injuries, Traumatic
• Platelet Dysfunction
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Platelet mapping Thromboelastography
These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Carolinas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Nekludov M, Bellander BM, Blombäck M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. — View Citation

Ortíz 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. — View Citation

Reddoch KM, Pidcoke HF, Montgomery RK, Fedyk CG, Aden JK, Ramasubramanian AK, Cap AP. Hemostatic function of apheresis platelets stored at 4°C and 22°C. Shock. 2014 May;41 Suppl 1:54-61. doi: 10.1097/SHK.0000000000000082. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet function	Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography	Within 5 hours
Secondary	Mortality	Mortality will be compared to admission platelet inhibition	1-3 months
Secondary	Functional Independence Measure	Patient function as measured by Functional Independence Measure compared to platelet inhibition	6-12 months