Study Using Plasma for Patients Requiring Emergency Surgery

NCT01221389 | Withdrawn Phase 4

• 1 other identifier: OHREB#2010077-01H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhagic Shock; Blood Coagulation Disorders; Blood Products; Trauma; Ruptured AAA

Keywords

hemorrhage; plasma; coagulopathy; trauma

Outcome Measures

Primary Outcomes (1)

• Percentage of eligible participants who were recruited and randomized to full participation in trial as a measure of future success completion of a larger multicenter trial.

  The ability to randomize patients and have them receive AB+ plasma or colloid control early in their emergency surgery.

  24 hours

Secondary Outcomes (4)

• Allogeneic blood product exposure rate

  Up to 24 weeks (initial hospitalization period)

• Coagulation Status and Measures

  First 48 hours (initial postoperative period)

• Blood Loss

  First 24 hours

• Transfusion Complications

  Up to 24 weeks (initial hospitalization period)

Study Arms (2)

Colloid Control

ACTIVE COMPARATOR

Patients will receive 2 units of 250 ml of hydroxyethylated starch solution once they are sent to the OR for emergency surgery to address etiology for hemorrhagic shock.

Drug: Human Plasma

Plasma

ACTIVE COMPARATOR

Patients will receive 2 units of AB+ plasma once they are sent to the OR for emergency surgery to address etiology for hemorrhagic shock.

Drug: Human Plasma

Interventions

Human Plasma DRUG

Patients will receive either 2 units of AB+ plasma or 2 units of hydroxyethylated starch control solution once they are sent to the OR for emergency surgery to address etiology for hemorrhagic shock.

Also known as: non applicable

Colloid Control; Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Priority 1 life-saving surgery for hemorrhagic shock due to ruptured AAA or trauma
• Over 18 years of age

You may not qualify if:

• They will not receive any blood products for religious reasons
• If surgery is not for hemorrhagic shock (e.g. subdural evacuation)
• Plasma already administered for documented coagulation deficit (e.g. coumadin, hemophilia)
• Allergy to plasma (e.g. IgA deficiency) or known allergy to Voluven® solution
• Shock that is solely due to non-hemorrhagic reasons
• Allergy to any vitamin
• Vital signs absent

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

MeSH Terms

Conditions

Shock, Hemorrhagic; Blood Coagulation Disorders; Wounds and Injuries; Hemorrhage; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Study Officials

• David T Neilipovitz, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: October 15, 2010
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: May 8, 2023

Record last verified: 2023-05

Locations

CA (1)