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Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Severe Trauma and Critical Bleeding

Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Severe Trauma and Critical Bleeding

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000198628
Enrollment
150
Registered
2014-02-25
Start date
2014-04-01
Completion date
2017-03-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is an increasing body of evidence that the adoption of POC guided coagulation and haemostatic management algorithms in the severely injured trauma patient and in critical bleeding results in improved outcomes. We aim to critically evaluate our POC programme at the Gold Coast University Hospital (GCUH).

Interventions

ROTEM / Multiplate targeted transfusion protocol. The primary aim is to validate the use of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Trauma and Critically Bleeding patients. Trauma and critically bleeding patients undergoing treatment at the Gold Coast University Hospital will be managed according to a POC ROTEM and Multiplate targeted coagulation and haemostatic programme. Our

ROTEM / Multiplate targeted transfusion protocol. The primary aim is to validate the use of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Trauma and Critically Bleeding patients. Trauma and critically bleeding patients undergoing treatment at the Gold Coast University Hospital will be managed according to a POC ROTEM and Multiplate targeted coagulation and haemostatic programme. Our programme has been established with rigorous quality assurance and quality control procedures in accordance with strict clinical governance guidelines. Treatment algorithms have been developed from normal reference ranges reported in the literature and from peer reviewed algorithms in the medical literature from experienced centres. Anthropometric measurements will be obtained at admission before collecting about 5 mL venous blood in sodium citrate tubes for analysis on ROTEM and Multiplate at baseline: - On arrival in the Emergency department in trauma patients - Recognition of significant bleeding - After initial baseline blood testing another venous blood sample will be collected 10 minutes post haemostatic intervention until haemorrhage control is achieved or as directed by treating clinician. ROTEM tests (EXTEM, INTEM, FIBTEM and APTEM) and Multiplate tests (ADP, ASPI, TRAP) will be performed according to manufacturer’s recommendations. Multiplate testing will be performed on all patients with an altered level of consciousness who are unable to provide a history and those patients currently taking anti-platelet agents. All other aspects of care will be as per standard GCUH Trauma Management Guidelines.

Sponsors

Gold Coast University Hospital Critical Care Research Group
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

Severe Trauma: (one of) - Trauma Call - > 2 Body Areas Involved - Significant mechanism of injury Bleeding: (2 out of 3) - > 2 Units PRBC's in 2 hrs - Drop in Hb > 2g/l in 2 hours Haemodynamic instability

Exclusion criteria

Age < 18 years Futility of therapy or Imminent death expected

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026