Clinical Trial: Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Unfractionated Heparin in Acute Chest Syndrome: A Pilot Feasibility Randomized Controlled Trial of Unfractionated Heparin vs. Standard of Care in Acu

Brief 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.

Detailed Summary:
Sponsor: University of Pittsburgh

Current Primary Outcome: Time to hospital discharge [ Time Frame: 10 days ]

Duration of hospitalization


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Arterial oxygen saturation [ Time Frame: 7 days ]
    Duration of hypoxemia
  • Body temperature [ Time Frame: 7 days ]
    Duration of fever
  • White blood cell count [ Time Frame: 7 days ]
    Duration of leukocytosis
  • Visual Analog Scale for pain [ Time Frame: 7 days ]
    Duration of moderate to severe pain
  • Opioid administration per participant [ Time Frame: 7 days ]
    Total dose of opioids per participant
  • Units of red blood cells administered per participant [ Time Frame: 7 days ]
    Total number of units of red blood cells per participant
  • Percentage of participants transferred to intensive care unit [ Time Frame: 7 days ]
  • Percentage of participants requiring mechanical ventilation [ Time Frame: 7 days ]
  • Percentage of participants experiencing multiorgan dysfunction syndrome [ Time Frame: 7 days ]


Original Secondary Outcome:

  • Arterial oxygen saturation [ Time Frame: 7 days ]
    Duration of hypoxemia
  • Body temperature [ Time Frame: 7 days ]
    Duration of fever
  • White blood cell count [ Time Frame: 7 days ]
    Duration of leukocytosis
  • Visual Analog Scale for pain [ Time Frame: 7 days ]
    Duration of moderate to severe pain
  • Opioid administration per participant [ Time Frame: 7 days ]
    Total dose of opioids per participant
  • Units of red blood cells administered per participant [ Time Frame: 7 days ]
    Total number of units of red blood cells per participant
  • Percentage of participants transferred to intensive care unit [ Time Frame: 7 days ]
  • Percentage of participants requiring mechanical ventilation [ Time Frame: 7 days ]
  • Percentage of participants experiencing multiorgan dysfunction syndrome [ Time Frame: 7 days ]
  • Number of participants who develop a pulmonary embolism [ Time Frame: Within 36 hours of diagnosis of acute chest syndrome ]


Information By: University of Pittsburgh

Dates:
Date Received: March 25, 2014
Date Started: May 2014
Date Completion: May 2017
Last Updated: August 30, 2016
Last Verified: May 2016