Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2019-10-12
2026-12-31
Brief Summary
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This is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.
Detailed Description
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This is a prospective, open-label, cohort study using Wilate VWF replacement therapy, trough or minimum VWF levels of 100-150% will be maintained for delivery in women with VWD whose third trimester VWF levels are \<100%. This group is termed "non-correctors". Women with VWD whose third trimester VWF levels spontaneously rise to \>100% will be assigned to the "corrector" group, and these women will not receive VWF replacement therapy. All patients will receive tranexamic acid for 14 days postpartum. Outcome parameters will be assessed for all patients.
The investigators or qualified research personnel will approach all consecutive pregnant VWD patients until 65 non-corrector patients have completed the study protocol, and up to 30 corrector patients have completed the study protocol. Patients with gestational week 34-38 von Willebrand factor activity (VWF:Act) or von Willebrand factor ristocetin cofactor (VWF:RCo), and/or Factor VIII procoagulant activity (FVIII:C) less than 100 percent will be used to assign patients to the non-corrector group. When VWF collagen binding (VWF:CB) laboratory monitoring can be performed, patients with an isolated VWF:CB type 2 defect can also be enrolled.
Rate of primary postpartum hemorrhage, severe postpartum hemorrhage, secondary postpartum hemorrhage will be measured. Safety and secondary laboratory measures will be assessed.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-Corrector
Patients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.
Use of a postpartum diary and additional blood draws
A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
Several blood draws additional to what is expected for routine clinical care will also be taken.
VWF replacement therapy with Wilate
This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are \<100% in the third trimester of pregnancy
Tranexamic acid
This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Corrector
Patients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.
Tranexamic acid
This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Use of a postpartum diary and additional blood draws.
A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
Several blood draws additional to what is expected for routine clinical care will also be taken.
Interventions
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Use of a postpartum diary and additional blood draws
A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
Several blood draws additional to what is expected for routine clinical care will also be taken.
VWF replacement therapy with Wilate
This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are \<100% in the third trimester of pregnancy
Tranexamic acid
This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Use of a postpartum diary and additional blood draws.
A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
Several blood draws additional to what is expected for routine clinical care will also be taken.
Eligibility Criteria
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Inclusion Criteria
or
* A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:
* Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector
* Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group
Written informed consent from the patient prepartum, before gestational week 39
Exclusion Criteria
* Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
* Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
* Age less than 18 years
* Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments
18 Years
FEMALE
No
Sponsors
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Ergomed
INDUSTRY
Octapharma
INDUSTRY
University of Washington
OTHER
Responsible Party
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Jill Johnsen
Professor, School of Medicine: Hematology and Oncology
Principal Investigators
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Jill M Johnsen, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Barbara A Konkle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington Center for Bleeding Disorders
Peter A Kouides, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mary M. Gooley Hemophilia Center
Locations
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University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Bleeding & Clotting Disorders Institute
Peoria, Illinois, United States
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
New Orleans, Louisiana, United States
Oregon Health & Science University
Portland, Oregon, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Washington Center for Bleeding Disorders
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Julie Smith
Role: primary
Evangelia Louizos
Role: primary
Jemima Duroseau, BSN, RN, MPH
Role: primary
Lucy Sanchez
Role: primary
Jonathan Roberts, MD
Role: primary
Melody Benton, MPH,MAS,CCRP
Role: primary
Cynthia Campbell-Baird
Role: primary
Jadeah Jackson
Role: primary
Emily Powers
Role: primary
Sarah Ruuska, MPH
Role: primary
References
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James AH, Jamison MG. Bleeding events and other complications during pregnancy and childbirth in women with von Willebrand disease. J Thromb Haemost. 2007 Jun;5(6):1165-9. doi: 10.1111/j.1538-7836.2007.02563.x.
James AH, Konkle BA, Kouides P, Ragni MV, Thames B, Gupta S, Sood S, Fletcher SK, Philipp CS. Postpartum von Willebrand factor levels in women with and without von Willebrand disease and implications for prophylaxis. Haemophilia. 2015 Jan;21(1):81-7. doi: 10.1111/hae.12568. Epub 2014 Oct 21.
Drury-Stewart DN, Lannert KW, Chung DW, Teramura GT, Zimring JC, Konkle BA, Gammill HS, Johnsen JM. Complex changes in von Willebrand factor-associated parameters are acquired during uncomplicated pregnancy. PLoS One. 2014 Nov 19;9(11):e112935. doi: 10.1371/journal.pone.0112935. eCollection 2014.
Kouides PA. Present day management of inherited bleeding disorders in pregnancy. Expert Rev Hematol. 2016 Oct;9(10):987-95. doi: 10.1080/17474086.2016.1216312. Epub 2016 Aug 2.
Abbassi-Ghanavati M, Greer LG, Cunningham FG. Pregnancy and laboratory studies: a reference table for clinicians. Obstet Gynecol. 2009 Dec;114(6):1326-1331. doi: 10.1097/AOG.0b013e3181c2bde8.
Szecsi PB, Jorgensen M, Klajnbard A, Andersen MR, Colov NP, Stender S. Haemostatic reference intervals in pregnancy. Thromb Haemost. 2010 Apr;103(4):718-27. doi: 10.1160/TH09-10-0704. Epub 2010 Feb 19.
Huq FY, Kulkarni A, Agbim EC, Riddell A, Tuddenham E, Kadir RA. Changes in the levels of factor VIII and von Willebrand factor in the puerperium. Haemophilia. 2012 Mar;18(2):241-5. doi: 10.1111/j.1365-2516.2011.02625.x. Epub 2011 Sep 28.
Nichols WL, Hultin MB, James AH, Manco-Johnson MJ, Montgomery RR, Ortel TL, Rick ME, Sadler JE, Weinstein M, Yawn BP. von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung, and Blood Institute (NHLBI) Expert Panel report (USA). Haemophilia. 2008 Mar;14(2):171-232. doi: 10.1111/j.1365-2516.2007.01643.x.
Demers C, Derzko C, David M, Douglas J; Society of Obstetricians and Gynecologists of Canada. Gynaecological and obstetric management of women with inherited bleeding disorders. J Obstet Gynaecol Can. 2005 Jul;27(7):707-32. doi: 10.1016/s1701-2163(16)30551-5. English, French.
Mannucci PM, Franchini M, Castaman G, Federici AB; Italian Association of Hemophilia Centers. Evidence-based recommendations on the treatment of von Willebrand disease in Italy. Blood Transfus. 2009 Apr;7(2):117-26. doi: 10.2450/2008.0052-08.
Laffan MA, Lester W, O'Donnell JS, Will A, Tait RC, Goodeve A, Millar CM, Keeling DM. The diagnosis and management of von Willebrand disease: a United Kingdom Haemophilia Centre Doctors Organization guideline approved by the British Committee for Standards in Haematology. Br J Haematol. 2014 Nov;167(4):453-65. doi: 10.1111/bjh.13064. Epub 2014 Aug 12. No abstract available.
Stoof SC, van Steenbergen HW, Zwagemaker A, Sanders YV, Cannegieter SC, Duvekot JJ, Leebeek FW, Peters M, Kruip MJ, Eikenboom J. Primary postpartum haemorrhage in women with von Willebrand disease or carriership of haemophilia despite specialised care: a retrospective survey. Haemophilia. 2015 Jul;21(4):505-12. doi: 10.1111/hae.12635. Epub 2015 Feb 16.
Hawke L, Grabell J, Sim W, Thibeault L, Muir E, Hopman W, Smith G, James P. Obstetric bleeding among women with inherited bleeding disorders: a retrospective study. Haemophilia. 2016 Nov;22(6):906-911. doi: 10.1111/hae.13067. Epub 2016 Oct 5.
Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol. 1995 Jun;85(6):977-82. doi: 10.1016/0029-7844(95)00062-V.
Kirtava A, Drews C, Lally C, Dilley A, Evatt B. Medical, reproductive and psychosocial experiences of women diagnosed with von Willebrand's disease receiving care in haemophilia treatment centres: a case-control study. Haemophilia. 2003 May;9(3):292-7. doi: 10.1046/j.1365-2516.2003.00756.x.
Govorov I, Lofgren S, Chaireti R, Holmstrom M, Bremme K, Mints M. Postpartum Hemorrhage in Women with Von Willebrand Disease - A Retrospective Observational Study. PLoS One. 2016 Oct 25;11(10):e0164683. doi: 10.1371/journal.pone.0164683. eCollection 2016.
James AH, Cooper DL, Paidas MJ. A global quantitative survey of hemostatic assessment in postpartum hemorrhage and experience with associated bleeding disorders. Int J Womens Health. 2017 Jul 3;9:477-485. doi: 10.2147/IJWH.S132135. eCollection 2017.
Kujovich JL. von Willebrand disease and pregnancy. J Thromb Haemost. 2005 Feb;3(2):246-53. doi: 10.1111/j.1538-7836.2005.01150.x. No abstract available.
Other Identifiers
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STUDY00016309
Identifier Type: -
Identifier Source: org_study_id