Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Vascular Medicine Institute
Information provided by (Responsible Party):
Craig Seaman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02098993
First received: March 25, 2014
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Acute Chest Syndrome
Sickle Cell Disease
Drug: Unfractionated heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Time to hospital discharge [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Duration of hospitalization


Secondary Outcome Measures:
  • Arterial oxygen saturation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of hypoxemia

  • Body temperature [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of fever

  • White blood cell count [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of leukocytosis

  • Visual Analog Scale for pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of moderate to severe pain

  • Opioid administration per participant [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Total dose of opioids per participant

  • Units of red blood cells administered per participant [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Total number of units of red blood cells per participant

  • Percentage of participants transferred to intensive care unit [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Percentage of participants requiring mechanical ventilation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Percentage of participants experiencing multiorgan dysfunction syndrome [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Number of participants who develop a pulmonary embolism [ Time Frame: Within 36 hours of diagnosis of acute chest syndrome ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 homozygous sickle cell disease (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)
  • International normalized ratio greater than 1.5 (current admission)
  • Activated partial thromboplastin time greater than 40 seconds (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 anticoagulation for some other reason
  • Currently receiving antiplatelet agents
  • Currently receiving estrogen containing oral contraceptives
  • Estimated glomerular filtration rate less than 45 millimeters per min (current admission)
  • History of allergic reaction to intravenous radiocontrast material
  • Chest CT scan with pulmonary embolism protocol performed as standard of care (current admission)
  • Pregnant as determined by a urine pregnancy test (current admission)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098993

Contacts
Contact: Craig D Seaman, MD 412-958-9571 seamanc@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburg Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Craig D Seaman, MD    412-958-9571    seamanc@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Vascular Medicine Institute
Investigators
Principal Investigator: Craig D Seaman, MD University of Pittsburgh
Principal Investigator: Margaret Ragni, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Craig Seaman, Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02098993     History of Changes
Other Study ID Numbers: ACS13090197
Study First Received: March 25, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Sickle cell disease
Acute chest syndrome
Hemoglobinopathy
Hemolytic anemia
Heparin
Anticoagulant

Additional relevant MeSH terms:
Anemia, Sickle Cell
Syndrome
Acute Chest Syndrome
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014