Factor XI Levels in Acute Ischemic Stroke
3 other identifiers
observational
450
1 country
1
Brief Summary
The purpose of this study is to evaluate the utility of measuring coagulation factor activities in the setting of acute ischemic stroke, as potential markers of inherited thrombotic risk. The investigators will determine if relationships exist between coagulation factors, including factor VIII, factor IX, and factor XI and clinical diagnosis, classification, and outcome. The investigators will determine if any significant elevations of these factor activities are independent thrombotic risk factors. Null Hypothesis: There is no statistical difference between coagulation factors, including factors VIII, IX, or XI activity levels in patients having acute ischemic stroke as compared to acute stroke mimics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedAugust 4, 2011
August 1, 2011
2.2 years
April 28, 2009
August 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the relationship between elevated factors VIII, IX and XI and acute ischemic stroke as compared to other emergent events.
At time of incident stroke (baseline) and at early follow-up (30-60 Days post stroke).
Secondary Outcomes (4)
To determine the relationship between elevated factors VIII, IX and XI and stroke subtype.
30-60 Days post stroke
To determine if a relationship exists between elevated factors VIII, IX and XI and the clinical severity and stroke outcome.
30-60 Days post stroke
To determine if factors VIII, IX and XI level are different in the acute phase of ischemic stroke relative to chronic phase.
30-60 Days post stroke
To determine if a relationship exists between factors VIII, IX and XI levels and early stroke/TIA recurrence.
30-60 Days post stroke
Study Arms (2)
Factors VIII, IX and XI levels measured
Case group
Non Stroke patients
This is the control group. This group represents patients who were initially evaluated for stroke.
Eligibility Criteria
Consecutive patients presenting to the University of Utah Health Sciences Center Emergency Department.
You may qualify if:
- Those clinically diagnosed with acute ischemic stroke
- years of age or greater
You may not qualify if:
- Those without clinical diagnosis of acute ischemic stroke will be included in the control group.
- Patients with hemorrhagic strokes
- Inpatients who are evaluated through the Brain Attack protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Sheila B. Terry Memorial Research Fundcollaborator
Study Sites (1)
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
Related Publications (7)
Chandler WL, Rodgers GM, Sprouse JT, Thompson AR. Elevated hemostatic factor levels as potential risk factors for thrombosis. Arch Pathol Lab Med. 2002 Nov;126(11):1405-14. doi: 10.5858/2002-126-1405-EHFLAP.
PMID: 12421150RESULTMeijers JC, Tekelenburg WL, Bouma BN, Bertina RM, Rosendaal FR. High levels of coagulation factor XI as a risk factor for venous thrombosis. N Engl J Med. 2000 Mar 9;342(10):696-701. doi: 10.1056/NEJM200003093421004.
PMID: 10706899RESULTMinnema MC, Peters RJ, de Winter R, Lubbers YP, Barzegar S, Bauer KA, Rosenberg RD, Hack CE, ten Cate H. Activation of clotting factors XI and IX in patients with acute myocardial infarction. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2489-93. doi: 10.1161/01.atv.20.11.2489.
PMID: 11073857RESULTMurakami T, Komiyama Y, Masuda M, Karakawa M, Iwasaka T, Takahashi H. Evaluation of factor XIa-alpha 1-antitrypsin in plasma, a contact phase-activated coagulation factor-inhibitor complex, in patients with coronary artery disease. Arterioscler Thromb Vasc Biol. 1995 Aug;15(8):1107-13. doi: 10.1161/01.atv.15.8.1107.
PMID: 7627703RESULTSantamaria A, Oliver A, Borrell M, Mateo J, Belvis R, Marti-Fabregas J, Ortin R, Tirado I, Souto JC, Fontcuberta J. Risk of ischemic stroke associated with functional thrombin-activatable fibrinolysis inhibitor plasma levels. Stroke. 2003 Oct;34(10):2387-91. doi: 10.1161/01.STR.0000088642.07691.15. Epub 2003 Aug 28.
PMID: 12947154RESULTYang DT, Flanders MM, Kim H, Rodgers GM. Elevated factor XI activity levels are associated with an increased odds ratio for cerebrovascular events. Am J Clin Pathol. 2006 Sep;126(3):411-5. doi: 10.1309/QC259F09UNMKVP0R.
PMID: 16880142RESULTSalomon O, Steinberg DM, Koren-Morag N, Tanne D, Seligsohn U. Reduced incidence of ischemic stroke in patients with severe factor XI deficiency. Blood. 2008 Apr 15;111(8):4113-7. doi: 10.1182/blood-2007-10-120139. Epub 2008 Feb 11.
PMID: 18268095RESULT
Biospecimen
A small 2ml vial of spun plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Majersik, MD
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2009
First Posted
April 30, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 4, 2011
Record last verified: 2011-08