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Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Entegrion, Inc. Identifier:
First received: August 2, 2011
Last updated: February 6, 2017
Last verified: February 2017
This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.

Condition Intervention Phase
Coagulation Defects Biological: Spray-dried S/D-treated Plasma Drug: Spray-dried S/D-treated plasma Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

Further study details as provided by Entegrion, Inc.:

Primary Outcome Measures:
  • Incidence of treatment-emergent SAEs [ Time Frame: 12 weeks ]
    Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion

Secondary Outcome Measures:
  • Change from baseline of select coagulation factors [ Time Frame: 30 minutes post infusion ]
    To evaluate the recovery of select coagulation factors after infusion of 2 Resusix

  • Incidence of AEs [ Time Frame: 12 weeks ]
    To evaluate the incidence of AEs for up to 12 weeks after infusion of Resusix

Enrollment: 27
Study Start Date: November 2013
Study Completion Date: September 9, 2016
Primary Completion Date: September 9, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spray-dried S/D-treated plasma
Resusix (Spray-Dried Solvent/Detergent-Treated Plasma) uses source plasma from U.S.-licensed facilities as the starting material. Source plasma donors are selected from the AB blood type, which is considered a "universal" product.
Biological: Spray-dried S/D-treated Plasma
Infusion of 100 mL Spray-dried S/D-treated Plasma
Other Name: Resusix
Drug: Spray-dried S/D-treated plasma
Infusion of 200mL Spray-dried S/D-treated plasma
Other Name: Resusix
Biological: Spray-dried S/D-treated Plasma
Infusion of 500 mL Spray-dried S/D-treated plasma
Other Name: Resusix
Biological: Spray-dried S/D-treated Plasma
Infusion of 750 mL Spray-dried S/D-treated Plasma
Other Name: Resusix
Biological: Spray-dried S/D-treated Plasma
Infusion of 800 mL Spray-dried S/D-treated Plasma
Other Name: Resusix


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Subject must provide written informed consent for participation in this study and valid contact information.
  2. Subject must be a male or postmenopausal female.
  3. Subject must be at least 18 years of age and not older than 55 years of age.
  4. Subject must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, including no history or symptoms of respiratory or cardiac disease.
  5. Vital signs should be within normal limits at Screening:

    1. Body temperature within 97°F to 99°F
    2. Heart rate 45 to 100 beats per minute (bpm)
    3. Systolic blood pressure (SBP) within 90 to 140 mmHg and DBP within 50 to 90 mmHg.
  6. Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix

    1. PR interval within 120 and 200 mm/s
    2. QRS interval <120 mm/s
    3. QTc interval ≤440 mm/s
  7. Subject must have laboratory hematology values within following normal ranges:

    1. White blood cell count (WBC): 4,500 to 11,000/mL
    2. Platelet (PLT) count: 150,000 to 400,000/mL;
    3. Hemoglobin (Hb): 12.5 to 15.5 g/dL;
    4. Activated partial thromboplastin time (aPTT): 24.6 to 36.7 seconds;
    5. Normal PT, International Normalized Ratio (INR): 0.8 to 1.2;
    6. Protein C ≥90%, Protein S ≥77%;
    7. Antithrombin III levels (ATIII) ≥100%.
  8. Subject must have laboratory clinical chemistry values within normal range specified by the testing laboratory.
  9. BMI ≤30 kg/m2.
  10. Subject must have a negative toxicology screening panel (urine test including qualitative identification of PCP, barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine.)
  11. Subject must be a non-drinker (≤2 alcoholic beverages per week) and a non-smoker (any tobacco products within six months prior to Screening).
  12. Subject must have no history of recreational (including IV) drug use (by self-declaration).
  13. Subject must have the ability and willingness to attend frequent visits to the study center.

Exclusion Criteria:

  1. Subject with lower extremity deep vein thrombosis (DVT) at Screening.
  2. Subject has a history of coagulopathy or thromboembolic disease.
  3. Subject has a first degree family member with history of venous thromboembolic disease <55 years of age or arterial thromboembolic disease <45 years of age.
  4. Subject has documented drug allergies with well-described reactions.
  5. Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
  6. Subject is found to have positive NAT test for HIV, HBV or HCV.
  7. Subject has any murmurs, rubs, or gallops on cardiac auscultation.
  8. Subject has had a previous transfusion at any time.
  9. Subject is unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
  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 identifier: NCT01589666

United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Entegrion, Inc.
Principal Investigator: Bradley Vince, DO Vince & Associates Clinical Research, Inc.
  More Information

Responsible Party: Entegrion, Inc. Identifier: NCT01589666     History of Changes
Other Study ID Numbers: RSX-102
Study First Received: August 2, 2011
Last Updated: February 6, 2017

Keywords provided by Entegrion, Inc.:
Spray-dried Solvent/Detergent Plasma
Fresh Frozen Plasma

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on September 21, 2017