A Novel Strategy of ECMO Management Using Nafamostat for Regional Combined With Low Intensity Systematic Anticoagulation

NCT06676085 | Recruiting

• 1 other identifier: Nafamostat in ECMO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

ECMO is widely used in patients with refractory respiratory and/or circulatory failure.The data shows that the incidence of bleeding and thrombotic events is still above 40%,and it is closely related to the increase in mortality rate.Therefore, optimizing ECMO anticoagulation management to reduce bleeding and thrombotic events is a key scientific issue that urgently needs to be addressed.

Conditions

ECMO

Outcome Measures

Primary Outcomes (1)

• incidence of ECMO related bleeding or thrombotic events

  the incidence of ECMO related bleeding or thrombotic events,such as membrane oxygenator or tube thrombotic,local blooding.

  28 days

Study Arms (2)

New Anticoagulation Strategy Group

EXPERIMENTAL

Combination of nafamostat and unfractionated heparin for anticoagulation, adjusting the dosage of unfractionated heparin to maintain APTT in the body for 40-45 seconds, and adjusting the dosage of nafamostat to maintain APTT in the membranous lung for 50-60 seconds during ECMO

Drug: Nafamostat

control group

ACTIVE COMPARATOR

Anticoagulation with unfractionated heparin, regulating the dosage of unfractionated heparin to maintain APTT in the body for 50-60s during ECMO.

Drug: Heparin

Interventions

Nafamostat DRUG

Nafamostat combined with unfractionated heparin for anticoagulation

New Anticoagulation Strategy Group

Heparin DRUG

unfractionated heparin for anticoagulation

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age older than 18 years old
• received ECMO because of severe respiratory failure

You may not qualify if:

• anticoagulant contraindications
• cerebral infarction or suspected patients
• severe hypertension
• women in gestational and lactational period
• hemophilia
• allergic to heparin or Nafamostat
• unwilling or unable to complete the study

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Bing Sun

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

nafamostat; Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bing Sun, MD

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Sun, MD

CONTACT

+8613911151075; ricusunbing@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 18, 2024

Record last verified: 2024-10

Locations

CN (1)