Trauma, Multiple Clinical Trial
— SIDEOfficial title:
Shock Index To DEtect Low Plasma Fibrinogen In Trauma (SIDE)
Verified date | March 2017 |
Source | Masaryk Hospital Krajská zdravotní a.s. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.
Status | Completed |
Enrollment | 280 |
Est. completion date | February 28, 2017 |
Est. primary completion date | February 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations Exclusion Criteria: - possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy) - administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level - circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches) |
Country | Name | City | State |
---|---|---|---|
Czech Republic | University Hospital in Plzen | Plzen | |
Czech Republic | Masaryk Hospital in Usti nad Labem | Usti nad Labem |
Lead Sponsor | Collaborator |
---|---|
Masaryk Hospital Krajská zdravotní a.s. |
Czech Republic,
Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Røislien J, Eken T, Næss PA, Gaarder C. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014 Mar 26;18(2):R52. doi: 10.1186/cc13798. — View Citation
Levy JH, Szlam F, Tanaka KA, Sniecienski RM. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012 Feb;114(2):261-74. doi: 10.1213/ANE.0b013e31822e1853. Review. — View Citation
Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schöchl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013 Jul 12;17(4):R137. doi: 10.1186/cc12816. — View Citation
Schöchl H, Maegele M, Solomon C, Görlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012 Feb 24;20:15. doi: 10.1186/1757-7241-20-15. Review. — View Citation
Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1. | On admission |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05175872 -
Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit
|
||
Active, not recruiting |
NCT05873959 -
An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
|
||
Not yet recruiting |
NCT03115970 -
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma
|
N/A | |
Recruiting |
NCT02978950 -
SToP: Venous Thromboembolism Screening in the Trauma Population
|
N/A | |
Completed |
NCT04145271 -
Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage
|
||
Recruiting |
NCT05754190 -
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
|
||
Completed |
NCT05441787 -
The Usefulness of Inflammatory Markers to Predict Poor Outcomes for Trauma Patients
|
||
Terminated |
NCT03846024 -
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
|
N/A | |
Recruiting |
NCT05634109 -
Whole Blood in Trauma Patients With Hemorrhagic Shock
|
Phase 3 | |
Recruiting |
NCT06305819 -
Effectiveness of a Self-management Program After Traumatic Injury
|
N/A | |
Recruiting |
NCT03526029 -
Swiss Trauma Registry
|
||
Completed |
NCT03854591 -
A Snapshot Study of Patients Affected by Gunshot Related Injuries in Trauma in South Africa
|
||
Withdrawn |
NCT03380767 -
Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.
|
N/A | |
Terminated |
NCT00184470 -
Trauma Registration at St. Olavs Hospital 2000-2003
|
Phase 3 | |
Completed |
NCT03760302 -
Analgesia in ÖAMTC Helicopter Emergency Service in Austria
|