Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Patients with Blood Cancers

Status: active

This phase III trial compares the effect of tranexamic acid given via inhalation to usual care in treating pulmonary hemorrhage (bleeding in the lungs) in patients with blood cancers. Tranexamic acid is commercially available to treat bleeding when given by mouth (oral route) or as an injection. This trial may help researchers determine if giving tranexamic acid through an inhalation route via nebulizer can control pulmonary hemorrhage better than usual care.

Inclusion Criteria

Age >= 18 years old
Have a diagnosed hematological malignancy
Are actively receiving mechanical ventilation
Have evidence of pulmonary hemorrhage as defined by either * Persistently bloody secretions upon endotracheal tube suctioning, or * Evidence of diffuse alveolar hemorrhage or pulmonary hemorrhage by bronchoscopic examination
Signed informed consent by patient or if the subject lacks decision-making capacity, the subject’s legally authorized representative

Exclusion Criteria

Presence of a do not resuscitate (DNR), no escalation of care or comfort care order at the time of screening
Expected survival < 48 hours
Evidence of nasal or oral spillage likely to be the cause of bloody secretions
Patients requiring 100% FIO2
Known hypersensitivity to tranexamic acid
Treatment with inhaled tranexamic acid prior to screening
Acquired defective color vision
Subarachnoid hemorrhage
Deep venous or arterial thrombus diagnosed within the previous 3 months
Seizure disorder on active anti-epileptic therapies
Hypersensitivity to tranexamic acid or any of the ingredients
Pregnant women will not be eligible and have a negative pregnancy test prior to entering study
Patient receiving concurrent anti-fibrinolytic therapy
Confirmed active COVID-19 infection

PRIMARY OBJECTIVE:

I. To assess the benefit of using nebulized tranexamic acid versus the standard of care on 30 day mortality.

SECONDARY OBJECTIVES:

I. To assess the following outcomes when using nebulized tranexamic acid versus the standard of care:

Ia. 100 day, intensive care unit (ICU) and hospital mortality rate.

Ib. Ventilator days at day 30.

Ic. ICU and Hospital Length of Stay.

Id. Partial pressure arterial oxygen to fraction of inspired oxygen (PaO2:FIO2) ratio (or percent oxygen saturation [SpO2]:FIO2 ratio) changes over the first 14 days.

Ie. Time to resolution of pulmonary hemorrhage.

If. Rate of recurrence of pulmonary hemorrhage.

Ig. Rate of invasive procedures required to control pulmonary hemorrhage.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive tranexamic acid via inhalation every 8 hours (3 times per day) for at least 3 days (9 treatments) in the absence of disease progression or unacceptable toxicity. Patients who continue to have evidence of persistently bloody secretions may receive an additional 7 days of treatment (total of 10 days) at the discretion of the ICU provider.

ARM B: Patients receive usual care for pulmonary hemorrhage as per treating providers.

Patients are followed up on days 28 and 100 after enrollment.

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Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Patients with Blood Cancers

Inclusion Criteria

Exclusion Criteria

United States

Texas

Houston

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Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Patients with Blood Cancers

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