Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial
Abstract Background Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryop...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2017-05-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-017-1980-x |
| _version_ | 1811288775598276608 |
|---|---|
| author | James Winearls Martin Wullschleger Elizabeth Wake Catherine Hurn Jeremy Furyk Glenn Ryan Melita Trout James Walsham Anthony Holley Jeremy Cohen Megan Shuttleworth Wayne Dyer Gerben Keijzers John F Fraser Jeffrey Presneill Don Campbell |
| author_facet | James Winearls Martin Wullschleger Elizabeth Wake Catherine Hurn Jeremy Furyk Glenn Ryan Melita Trout James Walsham Anthony Holley Jeremy Cohen Megan Shuttleworth Wayne Dyer Gerben Keijzers John F Fraser Jeffrey Presneill Don Campbell |
| author_sort | James Winearls |
| collection | DOAJ |
| description | Abstract Background Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage. Methods/design The Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicentre, randomised controlled trial comparing FC to Cryo for fibrinogen supplementation in traumatic haemorrhage. This trial will utilise thromboelastometry (ROTEM®) to guide and dose fibrinogen supplementation. The trial will recruit 100 trauma patients at four major trauma centres in Australia. Adult trauma patients with evidence of haemorrhage will be enrolled on arrival in the trauma unit and randomised to receiving fibrinogen supplementation with either FC or Cryo. The primary outcome is the differential time to fibrinogen supplementation. There are a number of predetermined secondary outcomes including: effects of the intervention on plasma fibrinogen levels, feasibility assessments and clinical outcomes including transfusion requirements and mortality. Discussion The optimal method for replacing fibrinogen in traumatic haemorrhage is fiercely debated. In this trial the feasibility and efficacy of fibrinogen supplementation using FC will be compared to Cryo. The results of this pilot study will facilitate the design of a larger trial with sufficient power to address patient-centred outcomes. Trial registration ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016. |
| first_indexed | 2024-04-13T03:43:19Z |
| format | Article |
| id | doaj.art-28901218f30d4114836d323d4829436a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T03:43:19Z |
| publishDate | 2017-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-28901218f30d4114836d323d4829436a2022-12-22T03:04:05ZengBMCTrials1745-62152017-05-0118111110.1186/s13063-017-1980-xFibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trialJames Winearls0Martin Wullschleger1Elizabeth Wake2Catherine Hurn3Jeremy Furyk4Glenn Ryan5Melita Trout6James Walsham7Anthony Holley8Jeremy Cohen9Megan Shuttleworth10Wayne Dyer11Gerben Keijzers12John F Fraser13Jeffrey Presneill14Don Campbell15Gold Coast University HospitalGold Coast University HospitalGold Coast University HospitalSchool of Medicine, University of QueenslandEmergency Research, Townsville HospitalPrincess Alexandra HospitalTownsville HospitalSchool of Medicine, University of QueenslandSchool of Medicine, University of QueenslandSchool of Medicine, University of QueenslandMenzies Health Institute Queensland, Griffith UniversityAustralian Red Cross Blood ServiceGold Coast University HospitalCritical Care Research Group, The Prince Charles Hospital and University of QueenslandIntensive Care Unit, Royal Melbourne Hospital and University of MelbourneGold Coast University HospitalAbstract Background Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage. Methods/design The Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicentre, randomised controlled trial comparing FC to Cryo for fibrinogen supplementation in traumatic haemorrhage. This trial will utilise thromboelastometry (ROTEM®) to guide and dose fibrinogen supplementation. The trial will recruit 100 trauma patients at four major trauma centres in Australia. Adult trauma patients with evidence of haemorrhage will be enrolled on arrival in the trauma unit and randomised to receiving fibrinogen supplementation with either FC or Cryo. The primary outcome is the differential time to fibrinogen supplementation. There are a number of predetermined secondary outcomes including: effects of the intervention on plasma fibrinogen levels, feasibility assessments and clinical outcomes including transfusion requirements and mortality. Discussion The optimal method for replacing fibrinogen in traumatic haemorrhage is fiercely debated. In this trial the feasibility and efficacy of fibrinogen supplementation using FC will be compared to Cryo. The results of this pilot study will facilitate the design of a larger trial with sufficient power to address patient-centred outcomes. Trial registration ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016.http://link.springer.com/article/10.1186/s13063-017-1980-xFibrinogenTraumaHaemorrhageCryoprecipitateFibrinogen concentrateROTEM® |
| spellingShingle | James Winearls Martin Wullschleger Elizabeth Wake Catherine Hurn Jeremy Furyk Glenn Ryan Melita Trout James Walsham Anthony Holley Jeremy Cohen Megan Shuttleworth Wayne Dyer Gerben Keijzers John F Fraser Jeffrey Presneill Don Campbell Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial Trials Fibrinogen Trauma Haemorrhage Cryoprecipitate Fibrinogen concentrate ROTEM® |
| title | Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial |
| title_full | Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial |
| title_fullStr | Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial |
| title_full_unstemmed | Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial |
| title_short | Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial |
| title_sort | fibrinogen early in severe trauma study feisty study protocol for a randomised controlled trial |
| topic | Fibrinogen Trauma Haemorrhage Cryoprecipitate Fibrinogen concentrate ROTEM® |
| url | http://link.springer.com/article/10.1186/s13063-017-1980-x |
| work_keys_str_mv | AT jameswinearls fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT martinwullschleger fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT elizabethwake fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT catherinehurn fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT jeremyfuryk fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT glennryan fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT melitatrout fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT jameswalsham fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT anthonyholley fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT jeremycohen fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT meganshuttleworth fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT waynedyer fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT gerbenkeijzers fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT johnffraser fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT jeffreypresneill fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial AT doncampbell fibrinogenearlyinseveretraumastudyfeistystudyprotocolforarandomisedcontrolledtrial |