A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemo… (NCT02528708) | Clinical Trial Compass
WithdrawnPhase 1/2
A Program to Evaluate Riastap® and FIBTEM® for the Early Control and Treatment of Postpartum Hemorrhage (PERFECT PPH)
Stopped: The study never began.
0Started 2021-01
Plain-language summary
In this prospective, single-center, randomized, placebo-controlled, double-blind clinical trial, parturients with primary PPH are eligible for treatment with fibrinogen concentrate following both vaginal delivery and cesarean section complicated by an estimated blood loss (EBL) \>1000 mL and an ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, and uterotonic agents).
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent from participant
* Age ≥18 years and \<50 years
* Primary PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum
* Vaginal delivery or Cesarean delivery (irrespective of etiology of PPH, such as accreta), with EBL \>1000 mL and ongoing bleeding notwithstanding standard treatment measures (volume replacement, uterine massage, uterotonic agents)
* FIBTEM®- A10 \<18 mm (corresponding to a MCF value of \<20 mm and to a plasma fibrinogen level approximately \<3 g/L)
Exclusion Criteria:
* Refusal to give written informed consent
* Refusal to receive blood transfusion
* Known inherited deficiencies of coagulation
* Personal history of thrombosis
* Either pre-pregnancy or ante-partum antithrombotic treatment due to increased risk of thrombosis
* Administration of Platelets, FFP or cryotherapy prior to study drug
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.