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Anticoagulant

Subcutaneous Heparin for Respiratory Insufficiency

Phase 4

Waitlist Available

Led By Gary Schwartz, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of two different methods of anticoagulation during a medical procedure called extracorporeal membrane oxygenation.

Eligible Conditions

Respiratory Failure
Heparin
Extracorporeal Membrane Oxygenation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of bleeding complication

Incidence of deep venous thrombosis

Incidence of thrombotic complications requiring intervention

Secondary outcome measures

Mortality

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: subcutaneous heparin anticoagulationExperimental Treatment1 Intervention

Experimental arm

Group II: systemic intravenous anticoagulationActive Control1 Intervention

SOC arm

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,321 Total Patients Enrolled

2 Trials studying Respiratory Failure

125 Patients Enrolled for Respiratory Failure

Gary Schwartz, MDPrincipal InvestigatorBSWH

9 Previous Clinical Trials

386 Total Patients Enrolled

Media Library

Subcutaneous Heparin Anticoagulation (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04496362 — Phase 4

Respiratory Failure Research Study Groups: subcutaneous heparin anticoagulation, systemic intravenous anticoagulation

Respiratory Failure Clinical Trial 2023: Subcutaneous Heparin Anticoagulation Highlights & Side Effects. Trial Name: NCT04496362 — Phase 4

Subcutaneous Heparin Anticoagulation (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04496362 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is subcutaneous heparin an accepted medical treatment by the FDA?

"Subcutaneous heparin anticoagulation has been approved, and thus our team gives it a score of 3."

Answered by AI

What is the cap on the number of research subjects for this experiment?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively looking for participants. The study was initially posted on 10/10/2018 and was last edited on 1/31/2022. The study is searching for 100 patients at 1 locations."

Answered by AI

Are people with the required credentials needed to participate in this trial currently being accepted?

"Correct, the listing on clinicaltrials.gov specifies that this trial is still looking for volunteers. This particular study was first posted on October 10th, 2018 and was updated as recently as January 31st, 2022. They are enrolling 100 individuals from a single site."

Answered by AI

Are there any other similar studies that have been conducted in the past?

"Subcutaneous heparin anticoagulation has been studied extensively since 2006, when the first clinical trial was sponsored by Ash Access Technology. This initial study involved 415 patients, and following its success, the drug received Phase 3 approval. Today, there are 45 active studies involving subcutaneous heparin anticoagulation taking place across 211 cities in 23 different countries."

Answered by AI

Are there other examples in which subcutaneous heparin has been used as an anticoagulant?

"45 clinical trials are currently underway to study subcutaneous heparin anticoagulation, with 15 of those in Phase 3. The majority of these trials are based in Sherbrooke, Quebec, but there are 389 locations for this kind of study in total."

Answered by AI

What conditions are traditionally treated with subcutaneous heparin anticoagulation?

"Subcutaneous heparin anticoagulation can be used to treat a variety of medical issues such as sprains, unstable angina pectoris, and other issues with medical devices."

Answered by AI

Recent research and studies

Annals of the American Thoracic SocietyJournal

Anticoagulation Practices During Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure. A Systematic Review

Sklar, Michael C., Eric Sy, Laurance Lequier, Eddy Fan, and Hussein D. Kanji. 2016. “Anticoagulation Practices During Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure. A Systematic Review”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.201605-364sr.

Annals of Intensive CareJournal

Predictive Factors of Bleeding Events in Adults Undergoing Extracorporeal Membrane Oxygenation

Aubron, Cécile, Joris DePuydt, François Belon, Michael Bailey, Matthieu Schmidt, Jayne Sheldrake, Deirdre Murphy, et al.. 2016. “Predictive Factors of Bleeding Events in Adults Undergoing Extracorporeal Membrane Oxygenation”. Annals of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/s13613-016-0196-7.

clinicaltrials.govStudy

Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study

2018. "Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04496362.

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