D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD

NCT ID: NCT03261284

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-12-30

Brief Summary

This was a prospective, cohort study.

Detailed Description

Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort. Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). All patients were followed up The occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.

Conditions

Extracorporeal Membrane Oxygenation Complication; Thrombosis; Hemorrhage; Heparin Overdose

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DIAMOND group

D-dimer and anti-Xa are mornitored. If D-dimer levels continue to rise (\>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (\<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).

Group Type: EXPERIMENTAL

D-dimer-guided adjustment stratege

Intervention Type: DIAGNOSTIC_TEST

D-dimer-guided adjustment stratege

Control group

Heparin dose adjusted according to anti-Xa activity or activated partial thromboplastin time (aPTT). The target range is aPTT 1.5 to 2.5 times the upper limit of normal or therapeutic anti-Xa levels (0.3 U/ml to 0.7 U/ml) for unfractionated heparin.

Group Type: ACTIVE_COMPARATOR

Thepeautic-heparin therapy

Intervention Type: DIAGNOSTIC_TEST

0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control

Interventions

D-dimer-guided adjustment stratege

D-dimer-guided adjustment stratege

Intervention Type: DIAGNOSTIC_TEST

Thepeautic-heparin therapy

0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Heparin

Eligibility Criteria

Inclusion Criteria

• Adult Patients
• Receiving ECMO surpport for any reason

Exclusion Criteria

• The duration of ECMO surpport was less than 24 hours .
• Those who had difficulty in compliance or were unavailable for follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan Asia Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Litao Zhang

Director of Thrombosis centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenlu ZHANG, MD,PhD

Role: STUDY_DIRECTOR

Wuhan Asia Heart Hospital

Locations

Zhang litao

Wuhan, Hubei, China

Countries

China

Other Identifiers

2017-P-032

Identifier Type: -

Identifier Source: org_study_id