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Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

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ClinicalTrials.gov Identifier: NCT02098993
Recruitment Status : Terminated (Poor enrollment.)
First Posted : March 28, 2014
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Vascular Medicine Institute
Information provided by (Responsible Party):
Craig Seaman, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Chest Syndrome Sickle Cell Disease Drug: Unfractionated heparin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Unfractionated heparin

Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.

The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.

 Drug: Unfractionated heparin
No Intervention: Standard of care
Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.


Outcome Measures
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Primary Outcome Measures :
  1. Time to Hospital Discharge [ Time Frame: Until hospital discharge ]
    Duration of hospitalization


Secondary Outcome Measures :
  1. Duration of Hypoxemia Assessed by Arterial Oxygen Saturation [ Time Frame: 7 days ]
    Arterial oxygen saturation less than 90%

  2. Duration of Fever Assessed by Body Temperature [ Time Frame: 7 days ]
    Body temperature greater than or equal to 38.0 degrees Celsius

  3. Duration of Leukocytosis Assessed by White Blood Cell Count [ Time Frame: 7 days ]
    White blood cell count greater than 10,000 per liter

  4. Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain [ Time Frame: 7 days ]
    Score of 4 or greater on the Visual Analog Scale for pain

  5. Opioid Administration Per Participant [ Time Frame: 7 days ]
    Total dose of opioids per participant

  6. Units of Red Blood Cells Administered [ Time Frame: 7 days ]
    Total number of units of red blood cells

  7. Percentage of Participants Transferred to Intensive Care Unit [ Time Frame: 7 days ]
  8. Percentage of Participants Requiring Mechanical Ventilation [ Time Frame: 7 days ]
  9. Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome [ Time Frame: 7 days ]
    Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098993


Locations
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United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Craig Seaman
Vascular Medicine Institute
Investigators
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Principal Investigator: Craig D Seaman, MD University of Pittsburgh
Principal Investigator: Margaret Ragni, MD, MPH University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Craig Seaman, University of Pittsburgh:
Study Protocol and Statistical Analysis Plan  [PDF] May 8, 2018

More Information
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Responsible Party: Craig Seaman, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02098993    
Other Study ID Numbers: ACS13090197
First Posted: March 28, 2014    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Craig Seaman, University of Pittsburgh:
Sickle cell disease
Acute chest syndrome
Hemoglobinopathy
 Hemolytic anemia
Heparin
Anticoagulant
Additional relevant MeSH terms:
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Acute Chest Syndrome
Anemia, Sickle Cell
Syndrome
Disease
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action