All-Case Surveillance of Prizbind®

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Prizbind®

• Registration Number: NCT02946931
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2016-11-18
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Results First Submitted: 2021-11-02
• Results First Submitted QC: 2021-11-02
• Results First Posted: 2021-12-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1402

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prizbind® for Intravenous Solution	Prizbind®	Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Drug Reactions (ADRs)	From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.	Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.

Secondary Outcome Measures

Name	Time	Method
Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	From the end of the first infusion up to 4 hours after the last infusion on Day 1.	Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.; Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.
Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)	From the end of the first infusion up to 4 hours after the last infusion on Day 1.	Number of patients in each category of maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported.; Maximum reversal was calculated as:｛(predose aPTT - minimum postdose aPTT)/(predose aPTT - upper limit of normal (ULN))｝ × 100%. If calculated reversal is \> 100, it was set to 100.; Maximum Reversal was categorized in the following 4 categories: 100% 80% \<= and \< 100% 50% \<= and \< 80% \< 50%