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Coagulation Factor Replacement

Prothrombin complex concentrate (Human) for Bleeding

Phase 4
Waitlist Available
Led By Gregory Nuttall, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will compare the use of Prothrombin Complex Concentrate (PCC) to Fresh Frozen Plasma (FFP) for post-operative bleeding and transfusion requirements in patients.

Eligible Conditions
  • Bleeding
  • Cardiac Surgery
  • Blood Loss
  • Prothrombin Complex Concentrate
  • Fresh Frozen Plasma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chest Tube Output
Cryoprecipitate (Cryo) Blood Product Transfusion
Fresh Frozen Plasma (FFP) Blood Product Transfusion
+2 more

Side effects data

From 2022 Phase 4 trial • 106 Patients • NCT02557672
37%
Renal Failure
10%
Prolonged mechanical ventilation
10%
Re-operation
8%
Renal Failure requiring dialysis
8%
ARDS
6%
Mesenteric ischemia
4%
Thromboembolic event
2%
Stroke/TIA
2%
STEMI
2%
Anaphylactic or allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fresh Frozen Plasma
Prothrombin Complex Concentrate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prothrombin complex concentrateExperimental Treatment1 Intervention
After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target ACT within 10% of baseline value. After protamine administration the ACT, CBC, PT/ INR, APTT, and fibrinogen, will be collected via preexisting arterial access. If ACT \>10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec will receive Prothrombin complex concentrate (Human) 15 units/kg.
Group II: Fresh frozen plasmaActive Control1 Intervention
After cardiopulmonary bypass, patients will receive protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, will be collected via preexisting arterial access. If ACT \>10% baseline additional protamine will be given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field will occur 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec will receive fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prothrombin complex concentrate (Human)
2016
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,308 Previous Clinical Trials
2,962,323 Total Patients Enrolled
4 Trials studying Bleeding
14,070 Patients Enrolled for Bleeding
CSL BehringIndustry Sponsor
198 Previous Clinical Trials
1,211,350 Total Patients Enrolled
1 Trials studying Bleeding
6 Patients Enrolled for Bleeding
Gregory Nuttall, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
1,681 Total Patients Enrolled
1 Trials studying Bleeding
80 Patients Enrolled for Bleeding
~12 spots leftby Oct 2025
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