A Clinical Study of Lyophilized Plasma in Patients on Warfarin
NCT ID: NCT01541098
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2015-01-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Response to Recombinant Factor VIIa When Administered for Bleed
NCT00104455
Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
NCT00004667
A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.
NCT02250560
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
NCT01790828
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
NCT01439971
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Licensed Plasma
Licensed Plasma
Plasma that has been authorized for transfusion.
Lyophilized Plasma
Lyophilized Plasma
Licensed plasma that has been lyophilized.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lyophilized Plasma
Licensed plasma that has been lyophilized.
Licensed Plasma
Plasma that has been authorized for transfusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
3. Patients with an elevated international normalized ratio.
Exclusion Criteria
2. Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
3. Patients who have received medications that could interfere with the results of laboratory testing.
4. Pregnant or nursing women.
5. Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
6. Patients previously enrolled in this study.
7. Active illicit drug use.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HemCon Medical Technologies, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-I-LyP-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.