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Could a simple shot replace IV blood thinners for ECMO patients?

NCT ID NCT04496362

Disease control Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if giving the blood thinner heparin as a shot under the skin is as safe and effective as the standard method of giving it through an IV for adults on ECMO (a machine that helps the lungs). The goal is to see if the shot method causes fewer bleeding or clotting problems. About 100 participants will be randomly assigned to one of the two approaches.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Respiratory failure requiring VV-ECMO support 3. Subject or appointed health care proxy/LAR is able to understand and sign the informed consent form Exclusion Criteria: 1. Subject currently enrolled in another interventional research trial 2. History of hypersensitivity/adverse reaction to heparin 3. Proven Heparin induced thrombocytopenia (HIT) 4. History of patent foramen ovale (PFO) 5. Recent surgery or other contraindication to systemic anticoagulation, e.g. intracranial bleed 6. Medical indication other than ECMO for systemic anticoagulation, e.g. pulmonary embolism

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Conditions

The condition(s) this trial relates to.

respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ECMO Heparin Respiratory failure

Contacts and locations

Locations

  • Baylor Scott & White Health research institute

    Dallas, Texas, 75246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.