Ignite Creation Date:
2024-05-06 @ 2:31 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04344860
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2020-04-09
Brief Title:
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease The VWD-WOMAN Trial
Sponsor:
Nicoletta C Machin
Organization:
University of Pittsburgh
Study Overview
Official Title:
Prospective Randomized Trial Comparing Recombinant Von Willebrand Factor rVWF Plus Tranexamic Acid vs rVWF Alone to Reduce Postpartum Hemorrhage in Women With Von Willebrand Disease The VWD-WOMAN Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This is a single-center randomized phase III clinical trial the VWD-Woman Trial in which 20 pregnant subjects with von Willebrand disease VWD defined as VWF ristocetin co-factor activity VWFRCo 050 IUml historic and previous history of bleeding are enrolled Subjects will include women with VWD age 18 years and older excluding those who have a bleeding disorder other than VWD Once enrolled subjects who meet all of the inclusion and none of the exclusion criteria will be randomized to recombinant Von Willebrand factor rVWF Vonvendi with Tranexamic Acid TA Cyclokapron or recombinant Von Willebrand factor rVWF Vonvendi alone to prevent postpartum hemorrhage after vaginal or caesarean delivery The primary endpoint is quantitative blood loss QBL by a labor suite nurse at delivery Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial Blood Assessment Chart PBAC transfusion blood products thromboembolic events and hysterectomy within 21 days and mechanism of PPH reduction by VWF assays VWFRCo VWFAg VIIIC fibrinogen and d-dimer Blood draws are at 5 time points including at 36 weeks gestation screening on admission for childbirth and at 1 day 2 days and 21 days after delivery The VWD-Woman Trial is considered greater than minimal risk as study drugs are given at delivery and special coagulation studies are obtained
Detailed Description:
The purpose of this 8-week single center randomized open-label phase III trial to compare recombinant von Willebrand factor rVWF Vonvendi plus tranexamic acid TA Cyclokapron vs rVWF alone to prevent postpartum hemorrhage PPH in women with Von Willebrand disease VWD VWD is an inherited bleeding disorder that occurs in 1 of the population It is caused by deficient or defective von Willebrand factor VWF Treatment at delivery is with VWF concentrate based on US and European guidelines and as DDAVP a non-VWF protein is contraindicated as it may cause hyponatremia low salt and seizures due to fluid replacement at delivery Yet blood loss is 15-fold greater in VWD than non-VWD controls The investigators believe this is due to physiologic protective fibrinolysis clot breakdown in the first 3 hours after delivery which may protect controls from excess clotting after delivery but which may increase bleeding in subjects with VWD PPH a significant cause of maternal morbidity and mortality in women PPH is defined as 1000 ml within the first 24 hours of vaginal or cesarean delivery PPH peaks in the first 2-3 hours postpartum a time during which there is early activation of the fibrinolytic system with a 2-fold increase TPA tissue plasminogen activator So while uterine atony is the major cause of PPH accounting for 63 of PPH cases but in 37 of cases uterotonic agents fail
TA is an anti-fibrinolytic therapy prevents clot breakdown which reduces bleeding and prevents clot breakdown in surgery trauma and in controls at delivery if it is given within 3 hours of delivery In the WOMAN trial a large trial of over 10000 women without bleeding disorders TA was safe and effective in reducing PPH when given intravenously in a vein within 3 hours of vaginal or cesarean delivery As TA is approved by the US Food and Drug Administration FDA to treat and prevent bleeding in VWD the investigators propose to study rVWF plus TA vs VWF alone to reduce PPH in subjects with VWD This is a pilot study to determine if recruitment randomization and study drug administration can be performed successfully and shows preliminary safety and efficacy in subjects with VWD rVWF Vonvendi will be administered by intravenous infusion before delivery and on day 1 and day 2 postpartum Tranexamic acid Cyclokapron will be administered by intravenous infusion within 3 hours postpartum Randomization will be at delivery to either rVWF at delivery and on day 1 and day 2 postpartum plus TA within three hours postpartum or rVWF alone at delivery and on day 1 and day 2 postpartum
TA is an anti-fibrinolytic therapy prevents clot breakdown which reduces bleeding and prevents clot breakdown in surgery trauma and in controls at delivery if it is given within 3 hours of delivery In the WOMAN trial a large trial of over 10000 women without bleeding disorders TA was safe and effective in reducing PPH when given intravenously in a vein within 3 hours of vaginal or cesarean delivery As TA is approved by the US Food and Drug Administration FDA to treat and prevent bleeding in VWD the investigators propose to study rVWF plus TA vs VWF alone to reduce PPH in subjects with VWD This is a pilot study to determine if recruitment randomization and study drug administration can be performed successfully and shows preliminary safety and efficacy in subjects with VWD rVWF Vonvendi will be administered by intravenous infusion before delivery and on day 1 and day 2 postpartum Tranexamic acid Cyclokapron will be administered by intravenous infusion within 3 hours postpartum Randomization will be at delivery to either rVWF at delivery and on day 1 and day 2 postpartum plus TA within three hours postpartum or rVWF alone at delivery and on day 1 and day 2 postpartum
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None