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

Not Applicable

Completed

Conditions: Haemorrhagic shock in trauma patients
Injury, Occupational Diseases, Poisoning

Registration Number: ISRCTN55509212

Lead Sponsor: HS Blood and Transplant Service (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility:<br>1. Proportion of patients in the intervention arm who receive cryoprecipitate within 90 minutes of admission <br>2. Recruitment rate (the proportion of eligible patients enroled)

Secondary Outcome Measures

Name	Time	Method
Clinical endpoints: <br>1. All cause mortality up to day 28 from randomisation <br>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 <br>3. Thrombotic events; venous thromboembolism (PE, DVT), arterial events (MI, stroke) to 3 months from randomisation <br>4. Organ failure as defined by single or multi-organ failure, to day 28 from randomisation <br>5. Length of hospital stay (including ITU or HDU stay) <br>6. Non-acute and acute transfusion reactions deemed to be related to cryoprecipitate up to day 28 from randomisation <br><br>Laboratory endpoints: <br>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 <br>2. Longitudinal changes in Clauss fibrinogen at days 7, 14, 21 and 28 from randomisation