An observational study in Blood Coagulation Disorders, Trauma and Acute Coagulopathy, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by University of Rochester · Observational
The purpose of the study is to evaluate the efficacy of the University of Rochester Medical Center's current Massive Transfusion Protocol.
Upon arrival of trauma level one designated patients the treating team evaluates the patient's 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 patient's 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.
457 studies on the registry are indexed under Blood Coagulation Disorders; 44 are open to participants now.
This study's enrollment of 2 is below the median of 100 across 207 observational studies indexed under Blood Coagulation Disorders.
Browse Blood Coagulation Disorders studies →University of Rochester is the lead sponsor of 728 studies on the registry; 115 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Study population includes level 1 trauma patients brought to the trauma bay for resusitation and are initiated under the Massive Transfusion Protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Trauma 1 massively transfused patients are identified as a Trauma level one patient by triage through guidelines from the Kessler Regional Trauma Center Trauma Triage Guidelines.
Other: Blood collection
After transfusion of each shipment of blood products outlined in the current Massive Transfusion Protocol one 2.7mL citrated blood sample will be collected from the subject through the 5th shipment of blood products. A final sample will be collected 24 hours following the discontinuation of the massive transfusion protocol.
Efficacy of Blood product ratio
Through thromboelastography testing the coagulopathy of trauma 1 patients receiving massive amounts of blood products in a ratio previously established by the institutions Standard of Procedure will be evaluated to determine the efficacy of the current blood product ratio.
Time frame: 24 hours
Haemostasis clot kinetics
Kinetics of clot formation analyzed by thromboelastograph over the course of the first 24 hours of resuscitation.
Time frame: 24 hours
Standard clinical data
Patient and trauma specific information will be extracted from the patients' record. Including but not limited to age, gender, type of injury and severity score, assessment of blood consumption score, blood type, number and volume of blood transfusions consumed during present trauma, current and past medical history and medications.
Time frame: 24 hours
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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