The primary objective is to compare the haemostatic effect of VHA-guided transfusion strategy versus optimized CCT guided transfusion strategy in haemorrhaging trauma patients. The secondary objectives of the study are to determine the effects of…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Injuries NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of subjects alive and free of massive
transfusion at 24 hours.
Secondary outcome
The secondary end points listed below will be analysed in order to provide a
sensitive and comprehensive description of outcomes and healthcare resource
demands for the intervention and control arm subjects:
* All-cause mortality at 6 and 24-hours and 28 & 90-days post admission.
* Duration and severity of coagulopathy until haemostasis, as defined by the
area under the time1 multiplied by PT/INR curve.2,3
* Proportion of patients who have corrected coagulopathy after first 8 units of
RBC.
* Time to haemostasis.1
* Time spent in coagulopathic condition until haemostasis.1
* Blood products (RBC, plasma, platelets alone and in total) first 6 and 24
hours after admission
* 28-day ventilator free days.
* 28-day ICU-free days.
* Total hospital length of stay.
* 28-day symptomatic thromboembolic events.
* Incidence of transfusion related complications.
* Incidence of organ dysfunction.
* Health care resource, productivity costs and HRQoL (EuroQol EQ-5DTM at
discharge or day 28, and at day 90).
* Lifetime health economic cost-effectiveness of personalized VHA-guided
haemorrhagic treatment versus MTP-based on best practice and CCT.
Background summary
In spite of improved resuscitation strategies, current transfusion therapy
still fails to correct coagulopathy during on-going haemorrhage. The mechanisms
and genesis of early trauma induced coagulopathy (TIC) have yet to be fully
elucidated, and there are many questions around how to optimally diagnose,
resuscitate and monitor the critically bleeding trauma patient.
It is important to detect TIC as early as possible. Conventional coagulation
tests (CCT), such as prothrombin time/international ratio (PT/INR), activated
partial thromboplastin time (APTT), fibrinogen concentration and platelet
counts, have traditionally been used. However, there is a striking lack of
evidence to support the use of these CCT to monitor resuscitation. Recent
published evidence describes an increasing recognition for the potential of
Viscoelastic Haemostatic Assays (VHAs), where functional coagulation status of
patient whole blood can rapidly and accurately be determined.
Study objective
The primary objective is to compare the haemostatic effect of VHA-guided
transfusion strategy versus optimized CCT guided transfusion strategy in
haemorrhaging trauma patients. The secondary objectives of the study are to
determine the effects of VHA-led versus optimized non-VHA guided resuscitation
on organ failure, hospital stay, critical care stay, health care resource needs
and mortality.
Study design
Multicentre, non-blinded, randomized controlled trial.
Intervention
Enrolled patients will be block randomized to either study arm:
* CONTROL: Haemostatic resuscitation, based on a MTP aiming at a ratio 1:1:1
of blood components (RBC 1: plasma 1: platelets 1) and CCT to guide further
resuscitation with blood products and procoagulant factors.
* INTERVENTION: Haemostatic resuscitation, based on a MTP aiming at a ratio
1:1:1 of blood components (RBC 1: plasma 1: platelets 1) and VHA-guiding
further resuscitation with blood products and procoagulant factors.
Study burden and risks
We expect the study to cause a minimum of discomfort to participants. The study
hypothesis is that VHA guided treatment is associated with a faster correction
of coagulopathy. Thereby, participants in this trial have a possible benefit.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Present with clinical signs of haemorrhagic shock
AND
- Activate the massive haemorrhage protocol and initiate first transfusion
- Randomised within 3 hours of injury and 1 hour of admission to the emergency department
- Informed consent is obtained within 24 hours after injury
Exclusion criteria
- Inclusion criteria are not met
- No informed consent obtained within 24 hours after injury.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56543.018.16 |