NCT02924792

Brief Summary

In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

December 8, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 4, 2016

Last Update Submit

December 7, 2017

Conditions

Hypovolemic ShockHemorrhagic Shock

Keywords

Intraosseous access

Outcome Measures

Primary Outcomes (2)

  • Flowrate of reinfusion of whole blood

    The total time of reinfusion of 450cc Whole blood

    45 minutes

  • Post transfusion hemolysis

    Hemolysis as measured by Haptoglobin and LD measures

    3 hours

Secondary Outcomes (1)

  • Success rate of sternal IO access

    30 minutes

Study Arms (3)

Reinfusion - Fast1

Case: Autologous reinfusion through Fast1 sternal needle. (Pyng Medical) CE marked/FDA Approved

Device: Reinfusion - Sternal IO needle

Reinfusion - T.A.L.O.N

Case: Autologous reinfusion through T.A.L.O.N sternal needle. (Vidacare) CE Marked/FDA approved

Device: Reinfusion - Sternal IO needle

Reinfusion - Intravenous line

Control: Autologous reinfusion through standard intravenous line

Device: Reinfusion - Intravenous needle

Interventions

Reinfusion - Sternal IO needleDEVICE
Reinfusion - Fast1Reinfusion - T.A.L.O.N
Reinfusion - Intravenous needleDEVICE
Reinfusion - Intravenous line

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy military officers

You may qualify if:

  • Male, Professional special forces military officers
  • Medically cleared for for military exercise or Activity
  • Signed standardized informed consent

You may not qualify if:

  • Participants who will not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

ShockShock, Hemorrhagic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhage

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 5, 2017

Last Updated

December 8, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.

Locations

NO(1)