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

Primary Purpose

Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

D-dimer-guided adjustment stratege

Thepeautic-heparin therapy

About this trial

This is an interventional treatment trial for Extracorporeal Membrane Oxygenation Complication focused on measuring D-dimer, Extracorporeal Membrane Oxygenation, heparin, anticoagulant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with non-valvular atrial fibrillation
Receiving warfarin therapy

Exclusion Criteria:

Patients who had suffered from recent (within 3 months) myocardial infarction, ischemic stroke, deep vein thrombosis, cerebral hemorrhages, or other serious diseases.
Those who had difficulty in compliance or were unavailable for follow-up.

Sites / Locations

Zhang litao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DIAMOND group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Thrombotic events

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

hemorrhagic events

cerebral hemorrhage,Gastrointestinal bleeding etc.

Secondary Outcome Measures

all-cause deaths

Full Information

NCT ID

NCT03261284

First Posted

August 22, 2017

Last Updated

April 13, 2023

Sponsor

Wuhan Asia Heart Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03261284

Brief Title

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

Acronym

DIAMOND

Official Title

D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Asia Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage, Heparin Overdose

Keywords

D-dimer, Extracorporeal Membrane Oxygenation, heparin, anticoagulant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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).

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DIAMOND group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

D-dimer-guided adjustment stratege

Other Intervention Name(s)

Heparin

Intervention Description

D-dimer-guided adjustment stratege

Intervention Type

Diagnostic Test

Intervention Name(s)

Thepeautic-heparin therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Thrombotic events

Description

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

Time Frame

24 months

Title

hemorrhagic events

Description

cerebral hemorrhage,Gastrointestinal bleeding etc.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

all-cause deaths

Description

all-cause deaths

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhenlu ZHANG, MD,PhD

Organizational Affiliation

Wuhan Asia Heart Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Zhang litao

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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