CRYOSTAT study: To determine whether early administration of cryoprecipitate in bleeding trauma patients is possible.

A feasibility study for a multi-centre, randomised controlled trial evaluating the effects of early administration of cryoprecipitate in major traumatic haemorrhage.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55509212

Enrollment

Registered

2012-09-13

Start date

2012-06-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Haemorrhagic shock in trauma patients Injury, Occupational Diseases, Poisoning

Interventions

(A) Early cryoprecipitate in addition to standard massive haemorrhage therapy (the intervention will be 2 adult pools over 15 minutes) (B) Massive haemorrhage therapy alone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent or agreement is obtained before any study related activity 2. The participant is judged to be 16 or above in UK and is affected by traumatic injury 3. The participant is deemed by the attending clinician to have ongoing active haemorrhage on admission AND REQUIRES 4. Activation of the local major haemorrhage protocol for management of severe blood loss

Exclusion criteria

Exclusion criteria: 1. The patient has been transferred from another hospital 2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life 3. More than 3 hours has elapsed from the time of injury

Design outcomes

Primary

Measure	Time frame
Feasibility: 1. Proportion of patients in the intervention arm who receive cryoprecipitate within 90 minutes of admission 2. Recruitment rate (the proportion of eligible patients enroled)	—

Secondary

Measure	Time frame
Clinical endpoints: 1. All cause mortality up to day 28 from randomisation 2. Bleeding outcomes, as assessed by numbers of all blood components transfused (PRBC, FFP, platelets, cryoprecipitate) at 6 hr, 24 hr and 28 days from randomisation 3. Thrombotic events; venous thromboembolism (PE, DVT), arterial events (MI, stroke) to 3 months from randomisation 4. Organ failure as defined by single or multi-organ failure, to day 28 from randomisation 5. Length of hospital stay (including ITU or HDU stay) 6. Non-acute and acute transfusion reactions deemed to be related to cryoprecipitate up to day 28 from randomisation Laboratory endpoints: 1. Longitudinal changes in Clauss fibrinogen, and ROTEM FIBTEM/EXTEM measurements (CA and MCF) at three pre-specified transfusion time points (after 4, 8 and 12 units of red cells), at 24 hours and 72 hours from randomisation 2. Longitudinal changes in Clauss fibrinogen at days 7, 14, 21 and 28 from randomisation	—

Measure

Time frame

Clinical endpoints: 1. All cause mortality up to day 28 from randomisation 2. Bleeding outcomes, as assessed by numbers of all blood components transfused (PRBC, FFP, platelets, cryoprecipitate) at 6 hr, 24 hr and 28 days from randomisation 3. Thrombotic events; venous thromboembolism (PE, DVT), arterial events (MI, stroke) to 3 months from randomisation 4. Organ failure as defined by single or multi-organ failure, to day 28 from randomisation 5. Length of hospital stay (including ITU or HDU stay) 6. Non-acute and acute transfusion reactions deemed to be related to cryoprecipitate up to day 28 from randomisation Laboratory endpoints: 1. Longitudinal changes in Clauss fibrinogen, and ROTEM FIBTEM/EXTEM measurements (CA and MCF) at three pre-specified transfusion time points (after 4, 8 and 12 units of red cells), at 24 hours and 72 hours from randomisation 2. Longitudinal changes in Clauss fibrinogen at days 7, 14, 21 and 28 from randomisation

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026