Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

NCT02098993 | Terminated Phase 2 Results DMC

• 1 other identifier: ACS13090197
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Chest Syndrome; Sickle Cell Disease

Keywords

Sickle cell disease; Acute chest syndrome; Hemoglobinopathy; Hemolytic anemia; Heparin; Anticoagulant

Outcome Measures

Primary Outcomes (1)

• Time to Hospital Discharge

  Duration of hospitalization

  Until hospital discharge

Secondary Outcomes (9)

• Duration of Hypoxemia Assessed by Arterial Oxygen Saturation

  7 days

• Duration of Fever Assessed by Body Temperature

  7 days

• Duration of Leukocytosis Assessed by White Blood Cell Count

  7 days

• Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain

  7 days

• Opioid Administration Per Participant

  7 days

Study Arms (2)

Unfractionated heparin

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.

Interventions

Unfractionated heparin DRUG

Unfractionated heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Craig Seaman: lead
• Vascular Medicine Institute: collaborator

Study Sites (1)

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Chest Syndrome; Anemia, Sickle Cell; Hemoglobinopathies; Anemia, Hemolytic

Interventions

Heparin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Anemia, Hemolytic, Congenital; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Craig Seaman, MD
• Organization: University of Pittsburgh

seamanc@upmc.edu

412-209-7308

Study Officials

• Craig D Seaman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Margaret Ragni, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: March 28, 2014
• Study Start: May 1, 2014
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)