Effect of prothrombin Concentrate complex on reverse of bleeding due to Rivaroxaban

Effect of prothrombin Concentrate complex on reverse of bleeding due to Rivaroxaban in critically ill patients admitted to intensive care unit

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20091012002582N20

Enrollment

Registered

2018-08-19

Start date

2017-11-22

Completion date

Unknown

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal finding of blood chemistry, major bleeding. Abnormal finding of blood chemistry, major bleeding due to coagulopathy

Interventions

Intervention 1: The intervention group will treat bleeding with P.C.C at 45-50 IU / Kg. Intervention 2: Control group:hemorrhage treatment will consist of 15-10 cc FFP per kilogram of body weight alon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who admitted in ICU with major bleeding and Life threatening related to Rivaroxaban

Exclusion criteria

Exclusion criteria: Unwillingness of the patient Allergic to PCC History of receiving antiplatelet drugs&NSAIDs

Design outcomes

Secondary

Measure	Time frame
The number of units transfused and blood products. Timepoint: From the bleeding time to the stop bleeding. Method of measurement: Measure the number of units transfused and blood products.	—

Primary

Measure	Time frame
He amount of bleeding in rivaroxaban use. Timepoint: duration of ICU stay. Method of measurement: blood loss volume and hemodynamic changes.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAta Mahmoodpoor

Tabriz University of Medical Sciences

ata.mahmoodpoor@gmail.com+98 41 3332 8009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026