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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03338660
Other study ID # 16-XXXX-SIUHN
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 15, 2018
Est. completion date July 15, 2020

Study information

Verified date May 2019
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.


Description:

Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 15, 2020
Est. primary completion date July 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Normal subjects

Exclusion Criteria:

- Pre existing antiplatelet drugs

Study Design


Related Conditions & MeSH terms

  • Platelet Dysfunction Due to Drugs

Intervention

Biological:
Infusion of Platelets
Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).
Infusion of Platelets
Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.
Placebo
Subjects will receive infusion placebo (saline).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Outcome

Type Measure Description Time frame Safety issue
Primary Change in platelet function Frozen platelets will result in improvement in platelet function after transfusion. 1 hour post-transfusion
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Completed NCT04342819 - The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study. Phase 2/Phase 3
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