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D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia

A

Ain Shams University

Status and phase

Unknown
Phase 4

Conditions

Coronavirus Disease (COVID)19

Treatments

Drug: low-molecular-weight heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT04584580
FMASU P35/ 2020

Details and patient eligibility

About

evaluation of the efficacy and safety of D-dimer adjusted heparin versus therapeutic dose heparin in patients with COVID-19 Pneumonia.

Full description

The following will be done for enrolled patients:

  1. Data collection: name, age, sex, special habits of medical importance (i.e. smoking, drug abuse), comorbid conditions.

  2. Clinical examination Vital data Local chest examination

  3. Measurement of oxygen saturation using pulse oximeter

  4. Laboratory investigations:

    Complete blood count with differential count Liver and kidney functions D-dimer level Coagulation profile

  5. Radiology work up ( Chest X-ray-High resolution computed tomography of the chest- computed tomography of the chest with pulmonary angiography as needed)

  6. Sepsis-induced coagulopathy score (SIC score)

  7. Sequential organ failure score (SOFA score)

  8. Patients will receive treatment according to the hospital guidelines for different disease stratification severity

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All adult (>18 years) patients from both sexes with COVID-19 pneumonia with positive nucleic acid test for severe acute respiratory syndrome Coronavirus (SARS-CoV-2) hospitalized either in the ward or intensive care unit

Exclusion criteria

  • Patients with absolute contraindication of pharmacological thromboprophylaxis and/ anticoagulation
  • Congenital hemorrhagic disorders
  • Hypersensitivity to heparin
  • Personal history of heparin-induced thrombocytopenia
  • Active major bleeding or conditions predisposing to major bleeding. Major bleeding is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g.intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level (Hb) of ≥2g/dL in a 24h period, or c) leads to transfusion of 2 or more units of whole blood or red blood cells (13).
  • Suspected or confirmed bacterial endocarditis
  • Ongoing or planned therapeutic anticoagulation for any other indication
  • Platelet count <50,000/μL within the past 24 hours or Hb level <8g/dL
  • Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
  • Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of age-appropriate local reference range within the past 24 hours
  • Fibrinogen <2.0 g/L
  • Severe renal impairment (CrCl<30 mL/min) or acute kidney injury
  • Use of dual antiplatelet therapy
  • Pregnancy
  • Unwillingness to consent

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Therapeutic dose low-molecular-weight heparin (LMWH)
Active Comparator group
Description:
Therapeutic dose low-molecular-weight heparin from admission until the end of hospital stay Enoxaparin 1 mg/kg subcutaneous every 12 hours
Treatment:
Drug: low-molecular-weight heparin
D-dimer levels and weight adjusted low-molecular-weight heparin (LMWH)therapy
Experimental group
Description:
from admission until the end of hospital stay. Patients will be stratified according to their body weight and D-dimer level and receive LMWH D-Dimer level Body Weight LMWH dose \<1 mg/dl \<100kg Enoxaparin 40mg OD 100-150kg Enoxaparin 40mg BD \>150kg Enoxaparin 60mg BD 1-3 mg/ dl \<100kg Enoxaparin 40mg BD 100-150kg Enoxaparin 80mg BD \>150kg Enoxaparin 120mg BD \>3 mg/ dl Enoxaparin 80mg BD
Treatment:
Drug: low-molecular-weight heparin

Trial contacts and locations

1

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Central trial contact

Ashraf Madkour

Data sourced from clinicaltrials.gov

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