Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083549
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2014-03-05
Brief Title:
Evaluating URMCs Massive Transfusion Protocol
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Evaluating the Efficacy of the University of Rochester Medical Centers Massive Transfusion Protocol in Trauma Level 1 Patients Utilizing Thromboelastography
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTP-TEG
Brief Summary:
The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Centers current Massive Transfusion Protocol
Upon arrival of trauma level one designated patients the treating team evaluates the patients injuries If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study Study procedures include collection of a blood sample following the transfusion of each shipment through shipment 5 of blood products outlined in the current Massive Transfusion Protocol
Each blood sample will be run on a Thromboelastograph to evaluate the patients hematostatic state through resuscitation One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph
Due to the critical need for medical intervention consent procedure will be waived at time of enrollment An authorized representative for the patient will be identified and approached to obtain consent for use of data collected
Upon arrival of trauma level one designated patients the treating team evaluates the patients injuries If the patient is initiated under the facilities Massive Transfusion Protocol and meets other inclusion and exclusion criteria the patient will be enrolled in the study Study procedures include collection of a blood sample following the transfusion of each shipment through shipment 5 of blood products outlined in the current Massive Transfusion Protocol
Each blood sample will be run on a Thromboelastograph to evaluate the patients hematostatic state through resuscitation One final blood sample will be collected 24 hours following the discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph
Due to the critical need for medical intervention consent procedure will be waived at time of enrollment An authorized representative for the patient will be identified and approached to obtain consent for use of data collected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None