Autopsy report · NCT01008436

Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.

“Lack of product due to industrial changes in the manufacturing process altering the final product.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 8 months before it stopped.
• 400 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Cardiochirurgia E.H.

Sponsor type

University, hospital or other

Conditions

Hemostasis

Interventions

Omni-stat Celox; Control

Participants

400

Sites

1

Countries

Italy

Trials that died the same way

• The Study for Evaluate of Satety and Dfficacy of Hemostatic Device
  “The company stopped manufacturing the product” (63% match in meaning)
• Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies
  “Manufacturing issues” (60% match in meaning)
• Clinical Evaluation of Systane® Balance in Dry Eye Subjects
  “Discontinuation of product development” (57% match in meaning)
• Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System
  “Product is no longer being manufactured and marketed.” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.