Status:
UNKNOWN
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
Lead Sponsor:
Medtrade
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for ...
Eligibility Criteria
Inclusion
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
- Female Adult subjects (\>18 years of age).
- Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery.
- Subjects with coagulation disorders can be included
- Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section.
- Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use.
- Subjects with PPH of cervical or vaginal origin.
Exclusion
- Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE).
- Pregnancy or incomplete multiple pregnancy
- Unresolved uterine inversion.
- Current cervical cancer.
- Current purulent infection of the vagina, cervix, uterus.
- Planned c-section with closed cervix.
- Patients requiring trans-abdominal insertion of Celox™ PPH.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06033170
Start Date
September 1 2023
End Date
October 1 2025
Last Update
September 13 2023
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