Overview

Study Using Plasma for Patients Requiring Emergency Surgery

Status:
Unknown status

Trial end date:
2012-12-01

Target enrollment:
0

Participant gender:
All

Summary

Information on the management of casualties from the ongoing conflicts in Afghanistan and Iraq has brought in to question the traditional approach to blood transfusion in hemorrhaging patients. Present recommendations for when to transfuse plasma products is when coagulation tests become abnormal. The proposed trial will investigate whether the more aggressive plasma transfusion strategies as advocated from researchers based on the Central Asian conflicts is valid. Since a study to determine the full impact of an altered plasma transfusion practice would require thousands of patients, a feasibility trial is appropriate and is being proposed. The hypotheses are thus: Primary Hypothesis- A multicentre trial that investigates the earlier use of plasma in patients with hemorrhagic shock going for emergency surgery will be feasible. Secondary Hypotheses- The early use of a universal donor blood plasma (AB+ plasma) in patients with shock due to blood loss (i.e. hemorrhagic) going for emergency surgery will reduce overall exposure to the total number of blood donor products (so-called allogeneic blood exposure). A reduction in allogeneic blood exposure would then reduce the total number of blood transfusion-related complications. The early use of this plasma product is safe and will not increase the incidence of blood clotting or other transfusion-related complications.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ottawa Hospital Research Institute

Treatments:

Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

1. Priority 1 life-saving surgery for hemorrhagic shock due to ruptured AAA or trauma

2. Over 18 years of age

Exclusion Criteria:

1. They will not receive any blood products for religious reasons

2. If surgery is not for hemorrhagic shock (e.g. subdural evacuation)

3. Plasma already administered for documented coagulation deficit (e.g. coumadin,
hemophilia)

4. Allergy to plasma (e.g. IgA deficiency) or known allergy to Voluven® solution

5. Shock that is solely due to non-hemorrhagic reasons

6. Allergy to any vitamin

7. Vital signs absent