NCT06096064

Brief Summary

Unfractionated heparin (UFH) is an anticoagulant to prevent thrombus formation or worsening of an existing thrombus. It is indicated for patients with deep vein thrombosis/pulmonary embolism (DVT/PE) or acute coronary syndrome (ACS). Unfractionated heparin treatment consists of an initial bolus followed by a continuous infusion that is adjusted based on the patient's subsequent partial thromboplastin time (PTT) levels

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

March 24, 2026

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

October 17, 2023

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidents of deviations from protocol

    Appropriate anticoagulation management will be measured using Percent time in therapeutic range based on aPTT levels

    30 Days

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

• Patient's aged 18 years or older with a confirmed diagnosis of DVT/PE based on imaging or a confirmed diagnosis of ACS requiring heparin therapy

You may qualify if:

  • Patient's aged 18 years or older with a confirmed diagnosis of DVT/PE based on imaging or a confirmed diagnosis of ACS requiring heparin therapy

You may not qualify if:

  • History of bleeding in the last 30 days
  • History of HIT
  • Use of systemic anticoagulants for another indication
  • Presence of coagulation disorder prior to admission (i.e. hemophilia, sickle cell anemia, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Richardson Medical Center

Dallas, Texas, 75082, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

October 31, 2022

Primary Completion

August 21, 2023

Study Completion

August 21, 2023

Last Updated

March 24, 2026

Record last verified: 2022-09

Locations