Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome
Status:
Terminated
Trial end date:
2018-06-27
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the feasibility of performing a larger multicenter
phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome
(ACS). Prespecified feasibility criteria consists of the ability to enroll potential study
participants, which includes the timely notification of hospitalized patients with ACS, the
capacity to consent eligible individuals, and the ability to appropriately randomize eligible
patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring
appropriate eligibility criteria, proper administration of the study drug, and the ability to
completely and accurately collect clinical data of interest. The final aim of our pilot study
is to provide preliminary data, with respect to treatment effect and variance, to allow
sample size calculation in a larger trial given the lack of data available to help guide this
process. The investigators hypothesize that the use of UFH in ACS will result in a decrease
in the duration of hospitalization and improve other clinical outcomes, such as the duration
of hypoxemia and duration of moderate to severe pain.