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Assessment of implication of Massive Transfusion Guidelines in conjunction with incidence of coagulopathy and outcome in the Northern Tasmania

Assessment of implication of Massive Transfusion Guidelines in conjunction with incidence of coagulopathy and outcome in the Northern Tasmania

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611001258943
Acronym
MTP
Enrollment
105
Registered
2011-12-07
Start date
2008-01-01
Completion date
2011-01-31
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

Massive transfusion (MT) is associated with serious often fatal complications including intractable disseminated intravascular coagulopathy (DIC). Therefore there is a growing need for guidelines and protocols that are addressing this issue. At a single institution we have implemented a MT-Protocol (MTP) in late 2007 and studied prospectively all patients (105) from Jan 2008 to Jan 2011 who required MT defined by replacement of half of blood volume within 4 hours with ongoing need for transfusion. The MTP included two phases and incorporated fixed volume of fresh frozen plasma (FFP), cryoprecipitate and platelets in addition to packed RBCs. The Launceston General Hospital is a tertiary referral centre for the North of Tasmania. This study will analyse data for the entire cohort of patients in Northern Tasmania who required Massive Transfusion.The main objective of the MTP is to provide appropriate and standardized different blood component therapy to prevent exsanguination, coagulopathy and thrombocytopaenia from occurring with subsequent inferior outcome. This study is aiming to avoid DIC and cease microbleeding as early as psossibel in MT setting and hence improving outcome. We conducted this study to demonstrate whether replacement of coagulation factors and platelets in timely fashion will influence outcome and also reduce DIC. This study, if published will deliver evidence based on local practice for a cohort of approximately 100-150 patients. This evidence would substantially improved evidence-based practice in trauma, surgery and emergency medicine.

Interventions

Patients that are requiring massive transfusion protocol (MTP) are included in this study after the initial issue and use of 4 Packed Red Cells Units (about half of blood volume) with foreseeable further blood transfusion. The MTP is activated as following MTP; Phase I protocol: 4 units Packed Red Cells + 2 units Fresh Frozen Plasma (300 ml each) + 1 Adult dose of platelets (depending upon availability) When notifying the ward that blood products are ready ask if they are continuing with the M

Patients that are requiring massive transfusion protocol (MTP) are included in this study after the initial issue and use of 4 Packed Red Cells Units (about half of blood volume) with foreseeable further blood transfusion. The MTP is activated as following MTP; Phase I protocol: 4 units Packed Red Cells + 2 units Fresh Frozen Plasma (300 ml each) + 1 Adult dose of platelets (depending upon availability) When notifying the ward that blood products are ready ask if they are continuing with the Massive Transfusion Protocol, if so continue by: Alternating with MTP; Phase II protocol: 4 units Packed Red Cells + 2 units Fresh Frozen Plasma (300 ml each) + 10 units Cryoprecipitate The requested physician at (Emergency Dept, Intensive care Unit (ICU) ot Theatre) will be asked when the blood products are delivered if they are continuing with the Massive Transfusion Protocol, and if so will continue alternating the above products as per protocol. After 10 units of packed cells have been issued ABO and Rh compatible blood may be issued at the discretion of the on-call Clinical Haematologist. This protocol was established by A/Professor A. Khalafallah in Sept 2007 at the Launceston General Hospital, Tasmania, Australia. The observation will be for 6 months for each subject.

Sponsors

none
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Patients from both sexes who presents with masive bleeding during the study period and who required MTP defined by transfusion of whole blood volume within 24 hours or replacement of half blood volume within 4 hours with ongoing need for transfusion.

Exclusion criteria

Patients who are not considered as per definition as massive transfusion

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026