Prostate CancerPhase 4NCT06144099
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery
A Phase 4 study testing fresh frozen plasma and prothrombin complex concentrate in people with Prostate Cancer and Spine, Open, run by Konkuk University Medical Center.
Trial summary
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Spine, Open, Hip Osteoarthritis
- What is being tested?
- fresh frozen plasma and prothrombin complex concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing spine surgery
- patients undergoing open radical prostatectomy
- patients undergoing hip arthroplasty
- patients undergoing knee arthroplasty
Who cannot join
- Patients taking oral anticoagulants,
- Patient taking recombinant factor VII a
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery.
- Conditions
- Prostate Cancer, Spine, Open, Hip Osteoarthritis, Knee Disease
- Being tested
- fresh frozen plasma, prothrombin complex concentrate
- Medical subject headings
- Prostatic Neoplasms, Spinal Dysraphism, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh frozen plasmaBiological
transfusion of fresh frozen plasma
prothrombin complex concentrateBiological
prothrombin complex concentrate administration
| Study group | Role | What they receive |
|---|---|---|
| fresh frozen plasma | Active comparator | according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed Receives: Biological: fresh frozen plasma |
| prothrombin complex concentrate | Experimental | according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration Receives: Biological: prothrombin complex concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration from the time diagnosing r-time prolongation to the time achieving bleeding control
Measured: 1 min
Secondary outcomes (8)
Red Blood Cell amount
Red Blood Cell transfusion amount during surgery
Measured: 1 hour
FFP amount
FFP transfusion amount during surgery
Measured: 1 hour
Platelet amount
Platelet transfusion amount during surgery
Measured: 1 hour
r-time
CK r-time after PCC or FFP
Measured: 10 min
CRT-MA
CRT-MA after PCC or FFP
Measured: 10 min
CFF-MA
CFF-MA after PCC or FFP
Measured: 10 min
Bleeding
Postoperative bleeding amount
Measured: 6 hour
oxygenation profile
PaO2/FiO2 ratio
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144099
- Sponsor's protocol ID
- HC22195220002002
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06144099
- Acronym / sponsor ID
- HC22195220002002
- Conditions
- Prostate Cancer, Spine, Open, Hip Osteoarthritis, Knee Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Nov 2023 (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 primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh frozen plasma | Active comparator | Biological: fresh frozen plasmaaccording to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed |
| prothrombin complex concentrate | Experimental | Biological: prothrombin complex concentrateaccording to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing spine surgery
- patients undergoing open radical prostatectomy
- patients undergoing hip arthroplasty
- patients undergoing knee arthroplasty
Key exclusion criteria (3 listed)
- Patients taking oral anticoagulants,
- Patient taking recombinant factor VII a
- pregnancy
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 plasmatransfusion of fresh frozen plasma | Biological | fresh frozen plasma |
| prothrombin complex concentrateprothrombin complex concentrate administration | Biological | prothrombin complex concentrate |
Primary outcome
duration from the time diagnosing r-time prolongation to the time achieving bleeding control
Time frame: 1 min
8 secondary outcomes
Red Blood Cell amount
Time frame: 1 hour
FFP amount
Time frame: 1 hour
Platelet amount
Time frame: 1 hour
r-time
Time frame: 10 min
CRT-MA
Time frame: 10 min
CFF-MA
Time frame: 10 min
Bleeding
Time frame: 6 hour
oxygenation profile
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fresh frozen plasma and prothrombin complex concentrate in people with Prostate Cancer and Spine, Open, run by Konkuk University Medical Center.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD PhD (+82-10-8811-6942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration from the time diagnosing r-time prolongation to the time achieving bleeding control (time frame: 1 min). 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 Jan 2024; AzTrials last refreshed its copy on 2 Nov 2026.