Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

Sickle Cell Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02098993
• Other study ID #: ACS13090197
• Status: Terminated
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: June 27, 2018

Study information

• Verified date: June 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Chest Syndrome
• Anemia, Sickle Cell
• Sickle Cell Disease
• Syndrome

Intervention

Drug:
• Unfractionated heparin

Locations

Country	Name	City	State
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Craig Seaman	Vascular Medicine Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Hospital Discharge	Duration of hospitalization	Until hospital discharge
Secondary	Duration of Hypoxemia Assessed by Arterial Oxygen Saturation	Arterial oxygen saturation less than 90%	7 days
Secondary	Duration of Fever Assessed by Body Temperature	Body temperature greater than or equal to 38.0 degrees Celsius	7 days
Secondary	Duration of Leukocytosis Assessed by White Blood Cell Count	White blood cell count greater than 10,000 per liter	7 days
Secondary	Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain	Score of 4 or greater on the Visual Analog Scale for pain	7 days
Secondary	Opioid Administration Per Participant	Total dose of opioids per participant	7 days
Secondary	Units of Red Blood Cells Administered	Total number of units of red blood cells	7 days
Secondary	Percentage of Participants Transferred to Intensive Care Unit		7 days
Secondary	Percentage of Participants Requiring Mechanical Ventilation		7 days
Secondary	Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome	Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual	7 days