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Therapeutic plasma exchange (TPE)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2134 SARS-CoV-2 convalescent plasma Wiki 0.58
drug2326 Standard of care Wiki 0.23

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity

Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood clots can occur in either veins or arteries and be large, like in stroke or heart attack, or very tiny, called microthrombi. Some patients with COVID-19 even have blood clots despite being on anti-clotting medications. Blood with increased viscosity does not flow through the body normally, in the same way that syrup, a highly viscous liquid, and water, a minimally viscous liquid, flow differently. The researchers believe that hyperviscosity may contribute to blood clots and organ damage seen in patients with severe COVID-19. Plasma exchange removes a patient's plasma, which contains the large sticky factors that the researchers believe are increasing viscosity, and replaces it with plasma from healthy donors. In addition to providing important information about plasma exchange as a treatment in COVID-19 for patients, this study will provide data to justify resource and staffing decisions. This study will enroll 20 participants who are critically ill from COVID-19. Participants will be randomized to receive therapeutic plasma exchange (TPE) or standard of care (SOC).

NCT04441996 COVID-19 Biological: Therapeutic plasma exchange (TPE) Other: Standard of care

Primary Outcomes

Description: Plasma viscosity will be measured in centipoise (cP). The normal range is 1.4 - 1.8 cP and measurements above this range indicate increased viscosity.

Measure: Change in Plasma Viscosity

Time: Baseline (Study Day 1 prior to TPE), up to Day 4 (within 24 hours of last TPE)

Secondary Outcomes

Description: The number of participants dying from any cause will be compared between study arms.

Measure: All Cause Mortality

Time: Up to Day 31

Description: The number of bleeding and thromboembolic complications will be compared between study arms. This endpoint is a composite outcome including any acute bleeding requiring transfusion support, venous thrombosis (deep vein thrombosis or pulmonary embolism), arterial clots (myocardial infarction, stroke, limb ischemia), renal replacement therapy or catheter line related clots.

Measure: Bleeding and Thromboembolic Complications

Time: Up to Day 31

Description: Time to treatment failure will be assessed in hours and is defined as plasma viscosity > 3.5 cP and/or the participant is a candidate for TPE as salvage therapy, as assessed by clinical team.

Measure: Time to Treatment Failure

Time: Up to Day 31

Description: The number of days spent in the ICU will be compared between study arms.

Measure: Duration of ICU Stay

Time: Up to Day 31

Description: The number of days spent in the hospital will be compared between study arms.

Measure: Duration of Hospital Stay

Time: Up to Day 31

Description: The number of participants in each study arm discharged to home or to a long-term acute care hospital, versus palliative care or death.

Measure: Discharge Disposition

Time: Up to Day 31

Description: The clinical status of participants will be assessed with a single-item, 12-point ordinal scale. A score of 1 indicates no evidence of infection and the severity of the clinical status increases as the number of necessary interventions increases to the final score of 12, which is death.

Measure: Change in Clinical Status

Time: Days 6, 10, 17, and 31

Description: Body temperature will be assessed in degrees Celsius.

Measure: Change in Body Temperature

Time: Days 6, 10, 17, and 31

Description: Systolic blood pressure will be assessed in millimeters of mercury (mm Hg).

Measure: Change in Systolic Blood Pressure

Time: Days 6, 10, 17, and 31

Description: Diastolic blood pressure will be assessed in millimeters of mercury (mm Hg).

Measure: Change in Diastolic Blood Pressure

Time: Days 6, 10, 17, and 31

Description: Heart rate will be assessed as beats per minute.

Measure: Change in Heart Rate

Time: Days 6, 10, 17, and 31

Description: Respiratory rate will be assessed as breaths per minute.

Measure: Change in Respiratory Rate

Time: Days 6, 10, 17, and 31

Description: The number of days participants are on a ventilator will be compared between study arms.

Measure: Change in Ventilator Days

Time: Days 6, 10, 17, and 31

Description: The oxygen percent delivered with a ventilator that is needed to maintain blood oxygen levels will be compared between study arms.

Measure: Change in Ventilator Oxygen Percent (FiO2)

Time: Days 6, 10, 17, and 31

Description: PEEP during ventilator use is measured in centimeters of water (cmH2O) and is the pressure in the lungs above atmospheric pressure, at the end of an exhalation. Higher PEEP (10 cmH2O or greater) may be associated with improved mortality, compared with PEEP below 10 cmH2O.

Measure: Change in Positive End-Expiratory Pressure (PEEP)

Time: Days 6, 10, 17, and 31

Description: Whether or not breathing assistance from vasopressors is needed will be compared between study arms.

Measure: Change in Vasopressor Requirements

Time: Days 6, 10, 17, and 31

Description: Whether or not breathing assistance from an RRT is needed will be compared between study arms.

Measure: Change in Need for Treatment from a Registered Respiratory Therapist (RRT)

Time: Days 6, 10, 17, and 31

Description: The Sequential Organ Failure Assessment (SOFA) score is a method of predicting mortality that is based on the degree of dysfunction of six organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). Each organ system is scored between 0 and 4, where 0 indicates normal function and 4 indicates a high degree of dysfunction.Total scores range from 0 to 24. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.

Measure: Change in Sequential Organ Failure Assessment (SOFA) Score

Time: Days 6, 10, 17, and 31

Description: The PaO2/FiO2 ratio is decreased with hypoxia. A value of less than 200 indicates acute respiratory distress syndrome (ARDS).

Measure: Change in Partial Pressure of Arterial Oxygen (PaO2)/Percentage of Inspired Oxygen (FiO2) Ratio

Time: Days 6, 10, 17, and 31

Description: Ventilatory ratio will be documented. The formula for the ventilatory is [minute ventilation (ml/min) × PaCO2 (mm Hg)]/(predicted body weight × 100 × 37.5).

Measure: Change in Ventilatory Ratio

Time: Days 6, 10, 17, and 31

Description: The normal range for WBC is 3,400 to 6,600 cells per microliter (cells/mL) of blood. A high WBC occurs when inflammation or infection is present.

Measure: Change in White Blood Count (WBC)

Time: Days 6, 10, 17, and 31

Description: Hemoglobin is measured in grams per deciliter (grams/dL). A normal Hb count for males is 13.2 to 16.6 grams/dL and a normal count for females is 11.6 to 15 grams/dL. A patient has anemia when their hemoglobin is low.

Measure: Change in Hemoglobin (Hb)

Time: Days 6, 10, 17, and 31

Description: A measure of hematocrit is the volume of red blood cells in the total blood volume. Normal hematocrit for males is 40 to 54% and a normal measurement for females is 36 to 48%

Measure: Change in Hematocrit (Hct)

Time: Days 6, 10, 17, and 31

Description: A normal platelet is 150,000 to 450,000 platelets per microliter of blood. An excess of platelets in the blood can be caused by inflammation or infection.

Measure: Change in Platelet Count

Time: Days 6, 10, 17, and 31

Description: MVP is a measurement of platelet size. Platelet size tends to be increased when platelet count is high. Typical platelet volume is 9.4 to 12.3 femtoliters (fL).

Measure: Change in Mean Platelet Volume (MVP)

Time: Days 6, 10, 17, and 31

Description: The normal range for BUN is 7 to 20 milligrams per deciliter (mg/dL) of blood. A high BUN value indicates that kidneys are not functioning well.

Measure: Change in Blood Urea Nitrogen (BUN)

Time: Days 6, 10, 17, and 31

Description: The normal range for creatinine is 0.84 to 1.21 mg/dL of blood. High serum creatinine indicates that kidneys are not functioning well.

Measure: Change in Creatinine

Time: Days 6, 10, 17, and 31

Description: For adults, normal values for total bilirubin are around 1.2 mg/dL of blood. High bilirubin indicates that the liver is not functioning well.

Measure: Change in Bilirubin

Time: Days 6, 10, 17, and 31

Description: The normal range for total protein is 6.0 to 8.3 g/dL of blood. High levels of total protein can occur with inflammation or infection while low levels may indicate kidney or liver problems, or malnutrition.

Measure: Change in Total Protein

Time: Days 6, 10, 17, and 31

Description: The normal range for albumin is 3.4 to 5.4 g/dL of blood. High albumin may indicate acute infection while low albumin can indicate malnutrition or liver disease.

Measure: Change in Albumin

Time: Days 6, 10, 17, and 31

Description: A normal value for CRP (with a standard test) is less than 10 milligrams per liter (mg/L) of blood. CRP increases with inflammation, which could be attributed to an infection, chronic inflammatory disease or heart disease.

Measure: Change in C-reactive Protein (CRP)

Time: Days 6, 10, 17, and 31

Description: A normal value for IL-6 is 1.8 picograms per milliliter (pg/mL) or less. IL-6 is increased in patients with infections or chronic inflammation.

Measure: Change in Interleukin 6 (IL-6)

Time: Days 6, 10, 17, and 31

Description: Prothrombin time is a measurement of the time it takes (in seconds) for blood to clot. A normal value is 10 to 14 seconds.

Measure: Change in Prothrombin Time (PT)

Time: Days 6, 10, 17, and 31

Description: An INR of around 1.1 is considered normal. Lower INR can means that blood is clotting faster than desired while higher INR indicates that blood is clotting slower than normal.

Measure: Change in International Normalized Ratio (INR)

Time: Days 6, 10, 17, and 31

Description: The aPTT test is a measurement of blood clotting time. Normal values for aPTT are around 30 to 40 seconds. Higher aPTT values can indicate a bleeding risk.

Measure: Change in Activated Partial Thromboplastin Time (aPTT)

Time: Days 6, 10, 17, and 31

Description: The anti-factor Xa assay measures plasma heparin and is useful with monitoring anticoagulation therapy. Interpretation of the resulting values depends on the anticoagulation medication used as well as the dosing schedule and indication. Patients not taking heparin should have an anti-Xa value of 0 units per milliliter (U/mL).

Measure: Change in Anti-factor Xa (anti-Xa)

Time: Days 6, 10, 17, and 31

Description: Fibrinogen is a protein that helps with the formation of blood clots. For adults, the normal range of fibrinogen is 200 to 400 mg/dL. Fibrinogen can be increased in patients with liver, kidney, or inflammatory diseases. The risk of developing a thromboembolism is increased with chronically high levels of fibrinogen.

Measure: Change in Fibrinogen

Time: Days 6, 10, 17, and 31

Description: The D-dimer blood test is a method of screening for deep vein thrombosis or pulmonary embolism. A normal D-dimer value is less than 0.50 micrograms per milliliter (mcg/mL) of blood. High levels of D-dimer can occur when a patient has a major blood clot, infection, or liver disease.

Measure: Change in D-dimer

Time: Days 6, 10, 17, and 31

No related HPO nodes (Using clinical trials)