Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid Hemorrhage
2 other identifiers
interventional
56
1 country
1
Brief Summary
The purpose of this study is to determine if giving blood transfusions to anemic patients with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
August 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
April 17, 2017
CompletedApril 17, 2017
March 1, 2017
7.8 years
August 26, 2009
March 5, 2017
March 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Oxygen Delivery in Vulnerable Brain Regions
Change in oxygen delivery after transfusion in brain regions with low baseline delivery.
1 hour
Secondary Outcomes (1)
Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery.
1 hour
Study Arms (1)
Transfusion
EXPERIMENTALInterventions
Transfusion of 1 unit of packed red blood cells over 1 hour.
Eligibility Criteria
You may qualify if:
- Aneurysmal SAH confirmed by angiography
- Hemoglobin \< 12.5 gm/dl
- One of the following:
- Considered at increased risk for vasospasm by care team
- Angiographic vasospasm
- Delayed ischemic deficit
- Able to be studied within 2 weeks after subarachnoid hemorrhage
You may not qualify if:
- Active Coronary Artery Disease
- Severe congestive heart failure
- Jehovah's witness
- Unable to obtain appropriately matched blood
- Other contraindications for transfusion
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University Medical Center
St Louis, Missouri, 63110, United States
Related Publications (1)
Dhar R, Zazulia AR, Videen TO, Zipfel GJ, Derdeyn CP, Diringer MN. Red blood cell transfusion increases cerebral oxygen delivery in anemic patients with subarachnoid hemorrhage. Stroke. 2009 Sep;40(9):3039-44. doi: 10.1161/STROKEAHA.109.556159. Epub 2009 Jul 23.
PMID: 19628806RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Diringer PI
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Diringer, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2009
First Posted
August 28, 2009
Study Start
November 1, 2007
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
April 17, 2017
Results First Posted
April 17, 2017
Record last verified: 2017-03