Implementing Treatment Algorithms for the Cure of Trauma Induced Coagulopathy (iTACTIC)

Implementing Treatment Algorithms for the Cure of Trauma Induced Coagulopathy (iTACTIC) - iTACTIC trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43543

Enrollment

Registered

2016-05-19

Start date

2016-06-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

blood clotting disorder Coagulopathy

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Inclusion criteria are not met - No informed consent obtained within 24 hours after injury.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of subjects alive and free of massive transfusion at 24 hours.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)