Pilot Study to Compare Fresh Frozen Plasma With 24-Hour Plasma in Babies Up to Age Six Months

NCT02774317 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB15-0795
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

With the advent of measures to try to decrease the incidence of transfusion-related acute lung injury (TRALI), the Blood Bank industry is attempting to avoid collection of plasma from female donors who have been pregnant in order to reduce the transfusion of plasma that may contain HLA antibodies. This has led to a decrease in the number of donors available for the production of fresh frozen plasma (FFP). Per Blood Bank regulatory standards in the United States, FFP must be frozen within 8 hours of collection. Plasma that is frozen within 24 hours of collection is called FP24, and it is produced when whole blood cannot be processed within the 8-hour time period for the generation of FFP. Studies of coagulation factors in FFP and FP24 have shown that coagulation factor activities are adequate to maintain hemostasis in both products. Many hospitals are using FFP and FP24 interchangeably in adults, and occasional hospitals are using these products interchangeably in neonates. However, studies concerning the use of FP24 in neonates have not been performed. The investigators propose a single center prospective pilot study comparing the clinical efficacy of FFP vs. FP24 in 50 nonsurgical neonates and babies up to age 6 months requiring plasma for an International Normalization Ratio (INR) of 1.5 or more. This protocol describes a pilot study to compare the use of FFP with FP24 in nonsurgical neonates. Use of plasma in these cases is mostly for patients with perinatal hypoxia or necrotizing enterocolitis and an INR of 1.5 or more. Transfusion of plasma (10 to 15 ml/kg) is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated by the patient's clinicians, and monitored with prothrombin time (PT), partial thromboplastin time (PTT), and INR.

Conditions

Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

• Number of neonates with corrected International Normalization Ratio (INR)upon transfusion with plasma frozen within 24 hours of collection (FP24)

  The investigators will compare fresh frozen plasma (FFP) with FP24 in correcting INR in 50 nonsurgical neonates

  24 hrs

Study Arms (2)

FFP

ACTIVE COMPARATOR

Patients receive FFP as clinically indicated (INR 1.5 or more)

Biological: Plasma

FP24

EXPERIMENTAL

Patients receive FP24 as clinically indicated (INR 1.5 or more)

Biological: Plasma

Interventions

Plasma BIOLOGICAL

FFP (plasma frozen within 8 hrs of collection) or FP24 (plasma frozen within 24 hrs of collection)

FFP; FP24

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Nonsurgical neonates and babies up to age 6 months with INR 1.5 or more who are deemed clinically to need plasma infusion.

You may not qualify if:

• Patients who are being prepared for surgery, or during or after surgery.
• Patients with congenital anomalies, chromosomal anomalies, or heart defects.
• Patients whose parents refuse to consent.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: May 17, 2016
• Study Start: October 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)