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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03182946
Other study ID # 08-16-22E
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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