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Coagulation Factor Replacement

Prothrombin complex concentrate (Human) for Hemorrhage

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

No Placebo-Only Group

Pivotal Trial

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

Hemorrhage
Cardiac Surgery
Blood Loss
Prothrombin Complex Concentrate
Fresh Frozen Plasma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

Renal Failure requiring dialysis

ARDS

Mesenteric ischemia

Thromboembolic event

Stroke/TIA

STEMI

Anaphylactic or allergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

Fresh Frozen Plasma

Prothrombin Complex Concentrate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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