Prehospital Kcentra for Hemorrhagic Shock | NCT04019015

Studies
Prehospital Kcentra for Hemorrhagic Shock

NCT04019015

Sponsor

Oregon Health and Science University

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

166Estimated

Phase

Phase 2

Conditions

Trauma Injury

Interventions

Prothrombin Complex Concentrate, Human
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 15, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Jun 2, 2019

First Submission Date that Met QC Criteria

Jul 11, 2019

First Posted Date

Jul 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot trial being performed to evaluate the feasibility, to include the ability of EMS to identify patients in shock and the ability to package, store, and administer Kcentra in the field.

Detailed Description

Prospective randomized trials have shown that 4-factor prothrombin complex concentrate (4FPCCs) result in more rapid correction of coagulopathy and greater likelihood of achieving hemostasis in patients receiving vitamin K antagonists who require emergent operations or who are bleeding. 4FPCCs have not been studied in the pre-hospital setting as a primary resuscitative adjunct. The investigators believe the effects of Kcentra to prevent or treat coagulopathy early after injury combined with its ability to treat the endotheliopathy of trauma and prevent organ failure will results in improved outcomes in severely injured trauma patients with hemorrhagic shock. The investigators have chosen to study a population of trauma patients in severe hemorrhagic shock (SBP < 70mmHg) because this population is at greatest risk for developing acute coagulopathy of trauma and has the greatest potential to benefit from the proposed therapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kcentra	Experimental	A single dose of Kcentra based on estimated body weight 2000 U for patients with an estimated body weight ≤ 75kg 3000 U for patients with an estimated body weight > 75kg	Drug: Prothrombin Complex Concentrate, Human
Placebo	Placebo Comparator	A single infusion of volume matched placebo solution (Normal Saline)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prothrombin Complex Concentrate, Human	Drug	Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors	Kcentra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of study drug administration	Number of study drug kits opened and given to patients prior to hospital arrival.	First 24 hours after injury

Secondary Outcomes

Measure	Description	Time Frame
Mortality	To evaluate mortality at 3 hour, 24 hour, and 30 days	First 30 days after injury
Hospital Free Days	Number of days out of the hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Trauma patients age 18 years or greater, or weight > 50 kg if age unknown
Systolic blood pressure < 70 mmHg
Suspicion of hemorrhagic shock based on mechanism of injury
EMS transport to a participating trauma center

Exclusion Criteria:

Age less than 18
Unknown time of injury
Out-of-hospital cardiopulmonary resuscitation
Known history of thromboembolic disorders or stroke or suspicion by EMS of a recent stroke
Known oral anti-coagulant use to include warfarin and novel anti-coagulants
Severe hypothermia (<28°C)
Drowning or asphyxia due to hanging
Burns more than 20% total body surface area
Evidence of devastating blunt traumatic brain injury to include fixed and dilated pupils, asymmetric pupils and extrusion of brain matter
Isolated blunt or penetrating head injury
Isolated spinal cord injury
Ground level (same level) falls
Inability to obtain intravenous access
Inability to administer randomized therapy within 4 hours of ambulance notification
Known transfers and inter-facility transfers
Known Do Not Resuscitate (DNR) prior to randomization
Known or suspected pregnancy
Known prisoners
Patients who have activated the "opt-out" process

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Martin A Schreiber, MD	Oregon Health and Science University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health & Science University		Portland	Oregon	97239	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000081084	Accidental Injuries
D012771	Shock, Hemorrhagic
D014947	Wounds and Injuries
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins