Postpartum haemorrhage MedDRA version: 14.1 Level: LLT Classification code 10036294 Term: Postpartum haemorrhage (primary) System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 14.1 Level: LLT Classification code 10043454 Term: Third-stage postpartum haemorrhage System Organ Class: 10036585 - Pre
Conditions
Interventions
Trade Name: RiaSTAP (bulk product)
Product Name: RiaSTAP (bulk product)
Product Code: Not applicable
Pharmaceutical Form: Lyophilisate for solution for
Sponsors
RACD Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Women Age 18 years or over 2) Women should have any one of the following within the first 12 hours after delivery: a) Haemorrhage of about 1500 mL and ongoing bleeding without another complication or b) Haemorrhage of about 1000 mL and ongoing bleeding with any of: i. caesarean section ii. uterine atony iii. placental abruption iv. placenta praevia v. Cardiovascular instability (arterial blood pressure below 90mm/Hg and heart rate greater than 100 bpm) vi. Clinical observation of microvascular oozing NB. Women can be included if they fulfill the inclusion criteria after delivery of the baby but where the bleeding had started in the antenatal period (antepartum haemorrhage). Women can be included where there is a slow accumulation of on-going blood loss (in the first 12 hours after delivery) if they fulfill the inclusion criteria. Participants will be eligible for randomisation and entry into the interventional phase of the study if there are both • On-going bleeding and • FIBTEM MCF =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Exclusion criteria The following groups will be excluded: 1) Women who have stated that they do not want to participate in the study during the antenatal period 2) Women declining infusion of red blood cells or blood components 3) Known inherited bleeding disorder 4) Placenta accreta diagnosed antenatally 5) Women who have already received uterine brace sutures, uterine tamponade balloons, radiology intervention or hysterectomy before entering the study 6) Clinical suspicion of amniotic fluid embolism 7) Secondary postpartum haemorrhage (haemorrhage which starts >12 hours after delivery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to establish whether giving fibrinogen (one of the body's blood clotting factors and it plays an important role is forming a strong clot) to women who are bleeding during childbirth and who have a low fibrinogen, reduces blood loss and reduces the amount of blood transfusion that women require.;Secondary Objective: Secondary objectives (i) To explore the effect of fibrinogen concentrate infusion on following efficacy endpoints: - the proportion of women receiving blood products within 24 hours after study medication - the number of units of red cell, fresh frozen plasma, cryoprecipiate and platelets transfused within 24 hours after study medication - the measured blood loss within 24 hours after study medication - the proportion of women requiring cryoprecipitate or fibrinogen concentrate as subsequent therapy within 24 hours after study medication - the proportion of women requiring invasive procedures (return to theatre, uterine brace sutures, uterine tamponade balloons, radiology intervention and hysterectomy) and the time of this intervention within 24 hours after study medication - Incidence and duration of breastfeeding (ii) To explore the effect of fibrinogen concentrate infusion on following safety endpoints: - the proportion of women requiring ITU/HDU admission and length of;Primary end point(s): This is a randomised double blind study comparing fibrinogen concentrate versus placebo. The primary outcome measure will be to compare: The total number of units of allogeneic blood products (red blood cells + fresh frozen plasma + cryoprecipitate + platelets) transfused within 24 hours after study medication between the two arms.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evalated at 24 hours after the study drug has been administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated between the time the study drug has been administered and 6 weeks.;Secondary end point(s): Efficacy endpoints: the proportion of women receiving no transfusion of allogeneic blood products within 24 hours after study medication the number of units of red blood cells, fresh frozen plasma, platelets and cryoprecipitate transfused within 24 hours after study medication the measured blood loss within 24 hours after study medication the proportion of women requiring cryoprecipitate or fibrinogen concentrate as subsequent therapy within 24 hours after study medication the proportion of women requiring invasive procedures (return to theatre, uterine brace sutures, uterine tamponade balloons, radiology intervention and hysterectomy) and the time of this intervention within 24 hours after study medication Safety endpoints: the proportion of women requiring ITU/HDU admission and length of stay the length of total hospital stay psychological impact of PPH on mothers' well being and breastfeeding rate (assessed by interview at 6 weeks follow up) the incidence of clinically diagnosed arterial and venous thromboembolism at 6 weeks follow up | — |
Countries
United Kingdom
Contacts
Public ContactJacqueline Nuttall
South East Wales Trials Unit (SEWTU, Cardiff University
Outcome results
None listed