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Study Using Plasma for Patients Requiring Emergency Surgery (SUPPRES)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01221389
First received: August 19, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Hemorrhagic Shock
Blood Coagulation Disorders
Blood Products
Trauma
Ruptured AAA
Drug: Human Plasma
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study Using Plasma for Patients Requiring Emergency Surgery: A Randomized Pilot Trial of Early Plasma for Patients Undergoing Emergency Surgery for Hemorrhagic Shock

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The ability to randomize patients and have them receive AB+ plasma or colloid control early in their emergency surgery.


Secondary Outcome Measures:
  • Allogeneic blood product exposure rate [ Time Frame: Up to 24 weeks (initial hospitalization period) ] [ Designated as safety issue: No ]
    The total allogeneic blood product exposure will be recorded.

  • Coagulation Status and Measures [ Time Frame: First 48 hours (initial postoperative period) ] [ Designated as safety issue: No ]
    The postoperative coagulation tests and presence/absence of a coagulopathy as measured by laboratory investigations and clinical correlation will be recorded and assessed.

  • Blood Loss [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]
    The total intraoperative blood loss will be recorded and any measurable blood loss from drains in the first 24 hours will also be recorded.

  • Transfusion Complications [ Time Frame: Up to 24 weeks (initial hospitalization period) ] [ Designated as safety issue: No ]
    We will measure outcomes that are or potentially related to blood product transfusions including TRALI, infections, transfusion reactions, thrombotic complications, organ failure(s) and mortality.


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Colloid Control
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
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.
Other Name: non applicable
Active Comparator: Plasma
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
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.
Other Name: non applicable

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221389

Contacts
Contact: David T Neilipovitz, MD 6137985555 ext 14169 dneilipovitz@toh.on.ca
Contact: Greg L Bryson, MD 6137985555 ext 14169 glbryson@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1Y4E9
Contact: David T Neilipovitz, MD    6137985555 ext 14169    dneilipovitz@toh.on.ca   
Principal Investigator: David T Neilipovitz, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: David T Neilipovitz, MD Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Dr David Neilipovitz, The Ottawa Hospital
ClinicalTrials.gov Identifier: NCT01221389     History of Changes
Other Study ID Numbers: OHREB#2010077-01H
Study First Received: August 19, 2010
Last Updated: July 19, 2011
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
hemorrhage
plasma
coagulopathy
trauma

Additional relevant MeSH terms:
Blood Coagulation Disorders
Emergencies
Hemostatic Disorders
Shock, Hemorrhagic
Cardiovascular Diseases
Disease Attributes
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Pathologic Processes
Shock
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014