Clinical trial NCT02098993: Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome
Official title: Unfractionated Heparin in Acute Chest Syndrome: A Pilot Feasibility Randomized Controlled Trial of Unfractionated Heparin vs. Standard of Care in Acute Chest Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Chest Syndrome
Sickle Cell Disease
Keywords: Sickle cell disease
Acute chest syndrome
Hemoglobinopathy
Hemolytic anemia
Heparin
Anticoagulant
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Vascular Medicine Institute
First posted: 2014-03-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ACS defined as a new pulmonary infiltrate involving at least one segment of the lung on a chest x-ray or chest CT scan with 2 or more of the following: chest pain, tachypnea, dyspnea, cough, hypoxemia, or body temperature greater than or equal to 38.0 degrees Celsius
* Hemoglobin electrophoresis confirming HbSS, SC, or B0 (historical records sufficient)
* Age greater than or equal to 18

Exclusion Criteria:

* Any absolute contraindication to heparin
* Platelet count less than 50 per microliter (current admission)
* Historical diagnosis of moyamoya disease as documented in medical records
* Historical diagnosis of proliferative retinopathy as documented in medical records
* Current participation in a chronic exchange transfusion program
* Underlying hypercoagulable disorder other than sickle cell disease
* Currently receiving therappeutic anticoagulation
* Currently receiving antiplatelet agents
* Currently receiving estrogen containing oral contraceptives
* Chest CT scan documented PE performed as standard of care prior to study enrollment (current admission)

Primary outcomes:
measure: Time to Hospital Discharge
timeFrame: Until hospital discharge
Secondary outcomes:
measure: Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
timeFrame: 7 days
measure: Duration of Fever Assessed by Body Temperature
timeFrame: 7 days
measure: Duration of Leukocytosis Assessed by White Blood Cell Count
timeFrame: 7 days
measure: Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain
timeFrame: 7 days
measure: Opioid Administration Per Participant
timeFrame: 7 days
measure: Units of Red Blood Cells Administered
timeFrame: 7 days
measure: Percentage of Participants Transferred to Intensive Care Unit
timeFrame: 7 days
measure: Percentage of Participants Requiring Mechanical Ventilation
timeFrame: 7 days
measure: Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome
timeFrame: 7 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Craig D Seaman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Margaret Ragni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: