Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

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

Tracking Information

• First Submitted Date: March 25, 2014
• First Posted Date: March 28, 2014
• Results First Submitted Date: May 28, 2019
• Results First Posted Date: July 16, 2019
• Last Update Posted Date: July 16, 2019
• Study Start Date: May 2014
• Actual Primary Completion Date: June 27, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 25, 2019)

Time to Hospital Discharge [ Time Frame: Until hospital discharge ]

Duration of hospitalization

Original Primary Outcome Measures (submitted: March 25, 2014)

Time to hospital discharge [ Time Frame: 10 days ]

Duration of hospitalization

Current Secondary Outcome Measures (submitted: June 25, 2019)

• Duration of Hypoxemia Assessed by Arterial Oxygen Saturation [ Time Frame: 7 days ]
  Arterial oxygen saturation less than 90%
• Duration of Fever Assessed by Body Temperature [ Time Frame: 7 days ]
  Body temperature greater than or equal to 38.0 degrees Celsius
• Duration of Leukocytosis Assessed by White Blood Cell Count [ Time Frame: 7 days ]
  White blood cell count greater than 10,000 per liter
• 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
• Opioid Administration Per Participant [ Time Frame: 7 days ]
  Total dose of opioids per participant
• Units of Red Blood Cells Administered [ Time Frame: 7 days ]
  Total number of units of red blood cells
• 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 ]
  Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual

Original Secondary Outcome Measures (submitted: March 25, 2014)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Chest Syndrome
• Sickle Cell Disease

• Intervention: Drug: Unfractionated heparin

Study Arms

• 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.

  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 27, 2018): 7
• Original Estimated Enrollment (submitted: March 25, 2014): 20
• Actual Study Completion Date: June 27, 2018
• Actual Primary Completion Date: June 27, 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02098993
• Other Study ID Numbers: ACS13090197
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Craig Seaman, University of Pittsburgh
• Original Responsible Party: Craig Seaman, University of Pittsburgh, Fellow
• Current Study Sponsor: Craig Seaman
• Original Study Sponsor: University of Pittsburgh
• Collaborators: Vascular Medicine Institute

Investigators

• Principal Investigator: Craig D Seaman, MD; University of Pittsburgh
• Principal Investigator: Margaret Ragni, MD, MPH; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: June 2019