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

NCT03261284 | Unknown DMC

• 1 other identifier: 2017-P-032
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective, cohort study.

Conditions

Extracorporeal Membrane Oxygenation Complication; Thrombosis; Hemorrhage; Heparin Overdose

Keywords

D-dimer; Extracorporeal Membrane Oxygenation; heparin; anticoagulant

Outcome Measures

Primary Outcomes (2)

• Thrombotic events

  Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.

  24 months

• hemorrhagic events

  cerebral hemorrhage,Gastrointestinal bleeding etc.

  24 months

Secondary Outcomes (1)

• all-cause deaths

  24 months

Study Arms (2)

DIAMOND group

EXPERIMENTAL

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).

Diagnostic Test: D-dimer-guided adjustment stratege

Control group

ACTIVE COMPARATOR

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.

Diagnostic Test: Thepeautic-heparin therapy

Interventions

D-dimer-guided adjustment stratege DIAGNOSTIC_TEST

D-dimer-guided adjustment stratege

Also known as: Heparin

DIAMOND group

Thepeautic-heparin therapy DIAGNOSTIC_TEST

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients
• Receiving ECMO surpport for any reason

You may not qualify if:

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

Sponsors & Collaborators

• Wuhan Asia Heart Hospital: lead

Study Sites (1)

Zhang litao

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenlu ZHANG, MD,PhD

  Wuhan Asia Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thrombosis centre

Model Details: 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).

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: March 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)