Anticoagulant ReversalPhase 2NCT04794348
Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin
A Phase 2 study testing Fresh Frozen Plasma (FFP) and Freeze Dried Plasma (FDP) in people with Anticoagulant Reversal, run by Teleflex at 1 site in United States.
Trial summary
The purpose of this research study is to see how well an experimental freeze dried plasma product, known as FDP, works to reverse the anticoagulation effects of a prescription medication called warfarin sodium (warfarin) compared to a licensed and routinely used plasma product known as fresh frozen plasma (FFP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant Reversal
- What is being tested?
- Fresh Frozen Plasma (FFP) and Freeze Dried Plasma (FDP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2021to Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a male or non-pregnant/non-breastfeeding female;
- Males must weigh ≥ 140 and ≤ 250 pounds; females must weigh ≥ 140 and ≤ 220 pounds;
- Be ≥ 18 and ≤ 65 years of age;
- Self-report that he or she feels well and healthy;
- Score ≥ 35 on the Duke Activity Status Index (see Appendix 3);
- Be eligible to make plasmapheresis donations based on the AABB Full-Length Donor History Questionnaire with the exception that subjects with a history of travel that puts them at risk for Creutzfeldt-Jakob Disease, malaria, West Nile virus, or Zika virus are eligible for this trial;
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- Males who have sex with men (MSM) and are in monogamous sexual relationships will be allowed to donate and participate in the trial. Other MSM relations will require a 3 month deferral period from the last sexual relation.
- Have read the educational materials about donating plasma and the information provided on diet, alcohol consumption, warfarin use, and restrictions during the trial;
- Be able and willing to provide written informed consent;
- Be available for the duration of the trial (approximately 18 to 28 weeks) and able to come to the treatment clinic for scheduled trial visits;
- Females should either be surgically sterile (hysterectomy or tubal ligation) or should use a highly effective, medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those that result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, condoms with spermicide, or vasectomized partner.
- All females must have a negative pregnancy test prior to enrollment. Post-menopausal females (women over 50 years of age who, in the absence of pregnancy, have a minimum of 2 months without menses) and females who have had a hysterectomy or oophorectomy will not be tested; and
- Understand the English language.
Who cannot join
- Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or untreated hypertension;
- Cancer of any kind (except basal cell) under treatment or resolved;
- Known or past coagulopathy conditions;
- Any medical conditions or medications on the American Association of Blood Banks (AABB) medical deferral list;
- Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
- Past diagnosis of stroke, deep vein thrombosis (DVT), venous or arterial thrombosis, blood clots, or transient ischemic attack;
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- Family history of venous or arterial thrombosis before the age of 50 in first-degree relatives (i.e., biological parents, full siblings, and/or children);
- D-dimer result > 2.0 FEU/mL;
- Subjects known to be deficient in protein C or protein S, or found to be deficient as assessed by the investigator based on the screening testing;
- History of diagnosed pathological arrhythmia;
- Current smoker (defined as having smoked any form of inhalant within the past 6 months);
- Subjects who are HIV negative and at high risk for contracting HIV who are currently using pre-exposure prophylaxis (PrEP®) as a prevention method;
- Known HIV or acquired immunodeficiency syndrome-related illness or received a positive test result for HIV infection;
- Positive test for hepatitis B virus, hepatitis C virus, human T-cell lymphotropic virus (HTLV), West Nile virus, Zika virus, or syphilis;
- History of significant treated or untreated mental health issues;
- Female subject who is pregnant, lactating, or with a positive pregnancy test;
- Currently taking an antibiotic or another medication for an infection;
- Treatment or use of aspirin (or other platelet-inhibiting agents) within 14 days of trial donation and infusion visits;
- Currently using any medications for anticoagulant therapy;
- Currently using any medications for antiplatelet therapy;
- Positive urine drug screen for one or more of the following: cannabinoids, cocaine, amphetamines, opiates, or PCP;
- Previous use of clotting factor concentrate(s);
- Receipt of blood or blood products within the past 12 months;
- In the past week, has had a headache and fever at the same time;
- Known intolerance to any excipients (citrate) in the investigational drug formulation. Intolerance is defined as any subject who exhibits severe symptoms of hypocalcemia after several blood donations;
- Systolic blood pressure > 140 mm Hg;
- Diastolic blood pressure > 90 mm Hg;
- Temperature > 100°F;
- Known hematocrit ≤ 39% for male donors and ≤ 38% for female donors;
- Positive direct antiglobulin test (DAT);
- Treatment with any investigational agent within 1 month before treatment infusion for this trial;
- Participation in any phase of any other investigational trials while participating in this trial;
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
- Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment;
- Institutionalized because of legal or regulatory order;
- Follows vegetarian or vegan diet; or
- Genetically predisposed to be resistant or highly sensitive to warfarin as indicated by having the extensive metabolizer genotypes, VKORC1 missense mutations and/or CYP2C9 variant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multisite, Double-Blind, Prospective Randomized, Crossover, Adequate and Well-Controlled Clinical Trial Assessing the Non-Inferiority of Autologous Freeze Dried Plasma (FDP) to Fresh Frozen Plasma (FFP) in Reversing the Anticoagulation Effects of Warfarin in Healthy Volunteers
The purpose of this research study is to see how well an experimental freeze dried plasma product, known as FDP, works to reverse the anticoagulation effects of a prescription medication called warfarin sodium (warfarin) compared to a licensed and routinely used plasma product known as fresh frozen plasma (FFP). The study hypothesis is that FDP is not inferior to FFP when used for this purpose.
Enrolled subjects are required to undergo a minimum of 4 plasmapheresis procedures, generating approximately 2,400 mL. Half will be used as FFP and half will be manufactured into FDP.
Read more
Each subject will receive a total of 6 autologous units (approximately 1,620 mL) of plasma product over the course of 2 infusion visits (approximately 810 mL per infusion visit) with a 14 day washout period between infusions.
Warfarin will be administered to each subject prior to each infusion visit. Subjects will be randomized to a treatment arm at their first warfarin administration visit leading up to the first infusion. This establishes the sequence of the plasma products to be infused across the 2 infusion visits. Those randomized to receive 3 units of FDP (approximately 810 mL) at the first infusion visit will receive the equivalent dose of FFP at their second infusion visit and vice versa for those randomized to receive 3 units of FFP at the first infusion visit.
FDP and FFP will be infused intravenously.
- Conditions
- Anticoagulant Reversal
- Being tested
- Fresh Frozen Plasma (FFP), Freeze Dried Plasma (FDP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen Plasma (FFP)Biological
Autologous units of fresh frozen plasma collected from the subject by plasmapheresis
Freeze Dried Plasma (FDP)Biological
Autologous units of freeze dried plasma manufactured from plasma collected from the subject by plasmapheresis
| Study group | Role | What they receive |
|---|---|---|
| Fresh Frozen Plasma (FFP) | Active comparator | Subjects will undergo plasmapheresis to generate approximately 1200 mL of fresh frozen plasma. After completion of warfarin dosing, approximately 810 mL of fresh frozen plasma will be intravenously administered to the subject. Receives: Biological: Fresh Frozen Plasma (FFP) |
| Freeze Dried Plasma (FDP) | Experimental | Subjects will undergo plasmapheresis to generate approximately 1200 mL, that will be manufactured into freeze dried plasma units. After completion of warfarin dosing, approximately 810 mL of freeze dried plasma will be intravenously administered to the subject. Receives: Biological: Freeze Dried Plasma (FDP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in International Normalized Ratio (INR)
Relative change in INR between pre-infusion baseline and the lowest INR recovery value measured within 6 hours post infusion using equivalent 3-unit doses of FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Occurrence of treatment emergent adverse events (TEAE)
Conclusions about safety will be based on the occurrence of TEAEs
Measured: Start of first plasma infusion through 14 day follow up visit post second plasma infusion
Secondary outcomes (12)
Changes in INR
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in aPTT
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in Factor II (FII)
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in Factor VII (FVII)
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in Factor IX (FIX)
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in Factor X (FX)
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in protein C
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Changes in protein S
changes between pre-infusion baseline and 6 hours post-infusion after infusion with FDP compared to FFP
Measured: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics area under the curve (AUC)
the AUC for FVII between pre-infusion baseline and 6 hours post infusion with equivalent 3 -unit doses (approximately 810 mL) of FDP vs FFP.
Measured: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics maximum concentration (Cmax)
the Cmax for FVII between pre-infusion baseline and 6 hours post infusion with equivalent 3 -unit doses (approximately 810 mL) of FDP vs FFP.
Measured: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics half-life (t1/2)
the t1/2 for FVII between pre-infusion baseline and 24 hours post infusion with equivalent 3 unit doses (approximately 810 mL) of FDP vs FFP
Measured: pre-infusion baseline, 24 hours post infusion
Thrombin generation assay (TGA)
Report and describe thrombin generation assay (TGA) results after infusion with FDP compared to FFP including lag time, peak amount, and ETP
Measured: 1 hour post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: This study was never started and is no longer planned for execution. We are now in the process of aligning to a new study design with the FDA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulant ReversalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teleflex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Army Medical Materiel Development Activity, Westat
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794348
- Sponsor's protocol ID
- S-18-04
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multisite, Double-Blind, Prospective Randomized, Crossover, Adequate and Well-Controlled Clinical Trial Assessing the Non-Inferiority of Autologous Freeze Dried Plasma (FDP) to Fresh Frozen Plasma (FFP) in Reversing the Anticoagulation Effects of Warfarin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04794348
- Acronym / sponsor ID
- S-18-04
- Conditions
- Anticoagulant Reversal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never started and is no longer planned for execution. We are now in the process of aligning to a new study design with the FDA.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TeleflexIndustry (pharma, biotech, devices)
- Collaborators
- United States Army Medical Materiel Development Activity, Westat
- Study start
- May 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see how well an experimental freeze dried plasma product, known as FDP, works to reverse the anticoagulation effects of a prescription medication called warfarin sodium (warfarin) compared to a licensed and routinely used plasma product known as fresh frozen plasma (FFP). The study hypothesis is that FDP is not inferior to FFP when used for this purpose.
Enrolled subjects are required to undergo a minimum of 4 plasmapheresis procedures, generating approximately 2,400 mL. Half will be used as FFP and half will be manufactured into FDP.
Each subject will receive a total of 6 autologous units (approximately 1,620 mL) of plasma product over the course of 2 infusion visits (approximately 810 mL per infusion visit) with a 14 day washout period between infusions.
Warfarin will be administered to each subject prior to each infusion visit. Subjects will be randomized to a treatment arm at their first warfarin administration visit leading up to the first infusion. This establishes the sequence of the plasma products to be infused across the 2 infusion visits. Those randomized to receive 3 units of FDP (approximately 810 mL) at the first infusion visit will receive the equivalent dose of FFP at their second infusion visit and vice versa for those randomized to receive 3 units of FFP at the first infusion visit.
FDP and FFP will be infused intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Frozen Plasma (FFP) | Active comparator | Biological: Fresh Frozen Plasma (FFP)Subjects will undergo plasmapheresis to generate approximately 1200 mL of fresh frozen plasma. After completion of warfarin dosing, approximately 810 mL of fresh frozen plasma will be intravenously administered to the subject. |
| Freeze Dried Plasma (FDP) | Experimental | Biological: Freeze Dried Plasma (FDP)Subjects will undergo plasmapheresis to generate approximately 1200 mL, that will be manufactured into freeze dried plasma units. After completion of warfarin dosing, approximately 810 mL of freeze dried plasma will be intravenously administered to the subject. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be a male or non-pregnant/non-breastfeeding female;
- Males must weigh ≥ 140 and ≤ 250 pounds; females must weigh ≥ 140 and ≤ 220 pounds;
- Be ≥ 18 and ≤ 65 years of age;
- Self-report that he or she feels well and healthy;
- Score ≥ 35 on the Duke Activity Status Index (see Appendix 3);
Key exclusion criteria (37 listed)
- Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or untreated hypertension;
- Cancer of any kind (except basal cell) under treatment or resolved;
- Known or past coagulopathy conditions;
- Any medical conditions or medications on the American Association of Blood Banks (AABB) medical deferral list;
- Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Frozen Plasma (FFP)Autologous units of fresh frozen plasma collected from the subject by plasmapheresis | Biological | Fresh Frozen Plasma (FFP) |
| Freeze Dried Plasma (FDP)Autologous units of freeze dried plasma manufactured from plasma collected from the subject by plasmapheresis | Biological | Freeze Dried Plasma (FDP) |
Primary outcome
Relative change in International Normalized Ratio (INR)
Time frame: pre-infusion baseline, 6 hours post infusion
Relative change in INR between pre-infusion baseline and the lowest INR recovery value measured within 6 hours post infusion using equivalent 3-unit doses of FDP compared to FFP
Occurrence of treatment emergent adverse events (TEAE)
Time frame: Start of first plasma infusion through 14 day follow up visit post second plasma infusion
Conclusions about safety will be based on the occurrence of TEAEs
12 secondary outcomes
Changes in INR
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in aPTT
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in Factor II (FII)
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in Factor VII (FVII)
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in Factor IX (FIX)
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in Factor X (FX)
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in protein C
Time frame: pre-infusion baseline, 6 hours post infusion
Changes in protein S
Time frame: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics area under the curve (AUC)
Time frame: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics maximum concentration (Cmax)
Time frame: pre-infusion baseline, 6 hours post infusion
Factor VII (FVII) kinetics half-life (t1/2)
Time frame: pre-infusion baseline, 24 hours post infusion
Thrombin generation assay (TGA)
Time frame: 1 hour post infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fresh Frozen Plasma (FFP) and Freeze Dried Plasma (FDP) in people with Anticoagulant Reversal, run by Teleflex at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in International Normalized Ratio (INR) (time frame: pre-infusion baseline, 6 hours post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.