NCT04507282

Brief Summary

Despite prophylactic anticoagulant treatments, thrombotic complications may develop in patients with Coronavirus disease 2019 (COVID-19). This study aimed to evaluate anti-Factor Xa levels to determine the anticoagulant activity of low molecular weight heparin (LMWH) in COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 7, 2020

Last Update Submit

August 15, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • subprophylactic anticogulation level

    \<0.2IU/ml

    14 days

Study Arms (1)

COVID 19 positive patients

Drug: LMWH

Interventions

LMWHDRUG

COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level

COVID 19 positive patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COVID 19 positive patients treated with LMWH

You may qualify if:

  • Patients older than 18 years, who were diagnosed with COVID-19 and were administered LMWH,
  • agreed to participate in the study were included

You may not qualify if:

  • Patients with previous coagulopathy,
  • continuous indication of anticoagulant therapy (atrial fibrillation (AF), valve disease),
  • glomerular filtration rate (GFR) \<30 mL/min or undergoing dialysis, or with known liver dysfunction were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yüksek İhtisas Hastanesi

Yıldırım, 16310, Turkey (Türkiye)

Location

Related Publications (1)

  • Ari S, Can V, Demir OF, Ari H, Agca FV, Melek M, Camci S, Dikis OS, Huysal K, Turk T. Elevated eosinophil count is related with lower anti-factor Xa activity in COVID-19 patients. J Hematop. 2020 Oct 8;13(4):249-258. doi: 10.1007/s12308-020-00419-3. eCollection 2020 Dec.

    PMID: 33046998DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor of Cardiology

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 11, 2020

Study Start

May 15, 2020

Primary Completion

July 1, 2020

Study Completion

July 15, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)