NCT02264730

Brief Summary

Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

October 6, 2014

Last Update Submit

October 14, 2014

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • control mild-to-moderate bleeding during surgery in which liver bleeding in encountered

    evaluated intermittently during those 12 weeks

    12 weeks

Secondary Outcomes (4)

  • Hemostatic Success

    1 minute

  • Hemostatic Success

    5 minutes

  • Hemostatic Success

    10 minutes

  • Hemostatic Success

    10 minutes

Study Arms (1)

Clot Foam

EXPERIMENTAL

Application of Clotfoam

Drug: ClotFoam

Interventions

ClotFoamDRUG

Patient has not received blood products between screenings

Also known as: No other names
Clot Foam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is expected to survive 6 months from the date of screening, If female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

You may not qualify if:

  • pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory

St Louis, Missouri, 63130, United States

RECRUITING

Related Publications (1)

  • Maegele M. Effective approaches to address noncompressible torso hemorrhage. Curr Opin Crit Care. 2024 Jun 1;30(3):202-208. doi: 10.1097/MCC.0000000000001141. Epub 2024 Feb 28.

    PMID: 38441108DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Grant Bochicchio, MD, MPH FACS

    Washington University School of Medicine Barnes Jewish Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 15, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)