Study Using Plasma for Patients Requiring Emergency Surgery (SUPPRES)
This study is currently recruiting participants.
Verified July 2011 by Ottawa Hospital Research Institute
Sponsor:
Ottawa Hospital Research Institute
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
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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:
- Priority 1 life-saving surgery for hemorrhagic shock due to ruptured AAA or trauma
- Over 18 years of age
Exclusion Criteria:
- 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
Contacts and Locations
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 Hemostatic Disorders Emergencies Shock Shock, Hemorrhagic Rupture Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Disease Attributes Pathologic Processes Hemorrhage Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013