Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370877
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2006-08-30
Brief Title:
rhuFVIIa in Post-partum Hemorrhage
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Recombinant Human Activated Factor VII as Salvage Therapy in Women With Severe Postpartum Hemorrhage
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII rhFVIIa given as a salvage therapy in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments We are going to compare its early use before elective surgery or arterial embolization to its late use after embolization or surgery before salvage hysterectomy
Detailed Description:
Depending on the country and the publications postpartum hemorrhage is either the first or the second cause of maternal death in the world including developed countries According to the WHO it is responsible for twenty two percent of maternal deaths In France postpartum hemorrhage accounts for five percent of delivery complications Three percent of them are severe leading to uncontrolled bleeding which intensity is higher than 1000 ml of blood during the 24 hours following delivery In France they are involved in 20 new deaths per year it is the first cause of maternal mortality Indeed it remains a significant source of morbidity severe anaemia blood transfusion transfusion complications acquired coagulation disorders and hemostatic hysterectomy
There are two different types of postpartum hemorrhage early and late hemorrhages Early hemorrhages are more common and occur in the first 24H after delivery Uterine atony is the main cause of early hemorrhage However visual assessment underestimates the amount of blood loss in around forty five percent of cases Emergency treatment is therefore sometimes undertaken with some delay giving time for disseminated intravascular coagulation DIC to occur which worsens the prognosis They are usually treated by medical resuscitation blood transfusion selective arterial embolisation and finally hysterectomy in case of ongoing uncontrolled bleeding Medical treatment and obstetric manoeuvres are usually effective Artificial delivery of the placenta should be performed immediately if the placenta is incomplete Afterwards oxytocin and prostaglandin derivatives are given At the same time anemia and hemostatic abnormalities are treated by transfusion of fresh frozen plasma and packed cells When the measures are insufficient surgery is necessary Bilateral ligation of hypogastric arteries or controlled embolisation is recommended In the case of uncontrolled bleeding hemostatic hysterectomy is performed as a salvage therapy Also the efficacy of ligation of the hypogastric arteries remains controversial Therefore the success rate of ligation of the hypogastric arteries is only forty two percent so that in many cases hysterectomy is required which induces a definitive sterility The development of interventional radiology has offered a new approach for the management of postpartum hemorrhage Many publications have showed the usefulness of the procedure whose success rate is around ninety percent However a specific technical plateau is needed which is far to be available at any place and at any moment For patients delivering far away from these technical sites limiting blood loss is crucial Among the methods aiming at limiting obstetrical hemorrhage special concern was given to recombinant activated factor VII a drug used with good therapeutic results in symptomatic patients with hemophilia and inhibitors It has already been applied in interventions situations
Taking into consideration the above described aspects our goal is thus to evaluate the potential medical interest of giving rhFVIIa early in the course of hemorrhage compared to giving it as a salvage therapy after arterial selective embolization or hysterectomy in patients still bleeding in order to avoid hemostatic hysterectomy
In the literature IV infusion of rFVIIa stopped ongoing diffuse hemorrhage rapidly and no further transfusion was required after rFVIIa injection Then rFVIIa might be a strong complementary agent in the management of major postpartum hemorrhage Optimal dose timing and safety characteristics of rFVIIa administration remain to be determined
Therefore the main objectives of the study are
1 to evaluate the reduction of the absolute risk of arterial embolizationsurgeryhysterectomy in patients receiving a unique early infusion of rhuFVIIa 60 µgkg body weight
2 to evaluate the number of women necessary to treat to avoid one arterial embolizationsurgeryhysterectomy
There are two different types of postpartum hemorrhage early and late hemorrhages Early hemorrhages are more common and occur in the first 24H after delivery Uterine atony is the main cause of early hemorrhage However visual assessment underestimates the amount of blood loss in around forty five percent of cases Emergency treatment is therefore sometimes undertaken with some delay giving time for disseminated intravascular coagulation DIC to occur which worsens the prognosis They are usually treated by medical resuscitation blood transfusion selective arterial embolisation and finally hysterectomy in case of ongoing uncontrolled bleeding Medical treatment and obstetric manoeuvres are usually effective Artificial delivery of the placenta should be performed immediately if the placenta is incomplete Afterwards oxytocin and prostaglandin derivatives are given At the same time anemia and hemostatic abnormalities are treated by transfusion of fresh frozen plasma and packed cells When the measures are insufficient surgery is necessary Bilateral ligation of hypogastric arteries or controlled embolisation is recommended In the case of uncontrolled bleeding hemostatic hysterectomy is performed as a salvage therapy Also the efficacy of ligation of the hypogastric arteries remains controversial Therefore the success rate of ligation of the hypogastric arteries is only forty two percent so that in many cases hysterectomy is required which induces a definitive sterility The development of interventional radiology has offered a new approach for the management of postpartum hemorrhage Many publications have showed the usefulness of the procedure whose success rate is around ninety percent However a specific technical plateau is needed which is far to be available at any place and at any moment For patients delivering far away from these technical sites limiting blood loss is crucial Among the methods aiming at limiting obstetrical hemorrhage special concern was given to recombinant activated factor VII a drug used with good therapeutic results in symptomatic patients with hemophilia and inhibitors It has already been applied in interventions situations
Taking into consideration the above described aspects our goal is thus to evaluate the potential medical interest of giving rhFVIIa early in the course of hemorrhage compared to giving it as a salvage therapy after arterial selective embolization or hysterectomy in patients still bleeding in order to avoid hemostatic hysterectomy
In the literature IV infusion of rFVIIa stopped ongoing diffuse hemorrhage rapidly and no further transfusion was required after rFVIIa injection Then rFVIIa might be a strong complementary agent in the management of major postpartum hemorrhage Optimal dose timing and safety characteristics of rFVIIa administration remain to be determined
Therefore the main objectives of the study are
1 to evaluate the reduction of the absolute risk of arterial embolizationsurgeryhysterectomy in patients receiving a unique early infusion of rhuFVIIa 60 µgkg body weight
2 to evaluate the number of women necessary to treat to avoid one arterial embolizationsurgeryhysterectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-005801-40 | EUDRACT_NUMBER | None | None |