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TerminatedNCT02606045VWDMinUpdated Jul 1, 2024Results posted

Minimize Menorrhagia in Women With Von Willebrand Disease

A Phase 3 interventional study of recombinant von Willebrand factor and tranexamic acid in Von Willebrand Diseases, sponsored by Margaret Ragni. Terminated at 19 sites in United States. Open to female participants aged 13 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Margaret Ragni · Phase 3, Interventional, and Treatment

Why this study was terminated
The study stopped early due to slow recruitment.
Phase
Phase 3
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
13 Years to 45 Years
Sex
Female
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Study summary

This is an outpatient, 24-week Phase III prospective, randomized, crossover trial comparing recombinant von Willebrand factor (rVWF) and tranexamic acid (TA, Lysteda®) to minimize menorrhagia in women with von Willebrand disease (VWD). The purpose of this Phase III multicenter prospective, randomized, crossover arm trial is to compare recombinant von Willebrand factor (rVWF) to tranexamic acid (TA) in reducing the severity of menorrhagia in women with von Willebrand disease.

Read the detailed description

In this study, women age 13-45 years with mild to moderate VWD and menorrhagia will be enrolled at their hemophilia treatment centers (HTCs) and provide information on menstrual bleeding from their two past monthly cycles to establish baseline bleeding frequency. Only women with regular menses, defined as menses every 21-35 days will be enrolled. A total of 60 subjects will be recruited and enrolled at approximately 25 HTC sites. Following enrollment, subjects will be randomized to Group I or Group II for the first five days of the next four consecutive menstrual cycles. Those randomized to Group I will be treated with Arm A for menstrual bleeding in cycles 1 and 2, followed by Arm B for menstrual bleeding in cycles 3 and 4. Those randomized to Group II will be treated with Arm B for menstrual bleeding in cycles 1 and 2, followed by Arm A for menstrual bleeding in cycles 3 and 4.

Subjects randomized to Group I will receive Arm A rVWF 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4. Subjects randomized to Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4. This regimen may be given at the HTC clinic or at home by visiting nurse. Baseline laboratory studies will be drawn at screening, including Blood Counts: hemoglobin, white count, differential, platelets; Iron Tests: iron, total iron binding capacity (TIBC), ferritin; Thyroid Test: thyroid stimulating hormone (TSH); and Von Willebrand Tests (VWF and related tests). Before initiating treatment, subjects will be trained by the HTC nurse on 1) reading urine pregnancy tests and 2) completion of the pictorial blood assessment chart (PBAC), cycle severity score (CSR), and cycle length (CL); and 3) completion of patient diary. Following randomization, subjects will administer home pregnancy tests prior to the first of each 5-day dosing cycle. On each of the four dosing cycles, Cycles 1-4, the PBAC, CSR, and CL will be recorded daily. After completion of study drug on cycle 2, the Crossover Study Visit will occur, during which subjects will be given a new supply of study drug for the study arm to which they will crossed over; subject diaries will be returned and coagulation studies and quality of life questionnaires performed. At 10-14 days after completion of study drug in Cycle 4, the End Study Visit will occur, during which subject diaries will be returned and quality of life questionnaires performed. All study visits will be within +/- 2 days of the scheduled visit. Study visits will be every 2 months, at the end of cycle 2 (cross-over) and at the end of cycle 4 (end of study) during which treatment diaries will be reviewed for bleeding frequency, side effects, and medications. Menstrual bleeding by PBAC, cycle severity, cycle duration, and health-related quality-of-life (HRQoL) questionnaires, including Rand Short Form 36-Question Health Survey (SF-36), Ruta Menorrhagia Severity Scale, Center for Disease Control Health-Related Quality of Life-14 Question Form (CDC-HRQoL14), and Center for Epidemiologic Studies Depression Scale (CES-D) will be assessed at baseline and after cycle 2 and after cycle 4. The study is innovative in the 1) evaluation of recombinant VWF, a new high purity recombinant VWF protein, to reduce menorrhagia, as compared with the current non-hormonal standard, tranexamic acid (TA); 2) investigation of the relationship of VWF to menstrual bleeding by PBAC score, by assessing VWD parameters: VWF ristocetin co-factor (VWF:RCo), VWF antigen (VWF:Ag), FVIII:C, VWF multimers, including high molecular weight multimers (HMW) by electrophoresis, and VWF genotype; 3) use of a "home treatment injection" for VWD; 4) comparison of two quality of life measures to assess treatment response on each study arm, one specific for bleeding disorders and one specific for menstrual disorders.

02

Conditions studied

  • Von Willebrand Diseases

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Keywords

  • menorrhagia
  • VWD
03

In context

Menorrhagia

186 studies on the registry are indexed under Menorrhagia; 32 are open to participants now.

This study's enrollment of 39 is below the median of 100 across 137 interventional studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

Margaret Ragni is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult females 13-45 years of age.
  2. Mild or moderate von Willebrand disease (VWF:RCo \<0.50 IU/ml, normal multimers, past bleeding)
  3. Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.
  4. Regular menses, at least every 21-35 days.
  5. Willingness to have blood drawn
  6. No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
  7. Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS) during the study.
  8. Willingness to comply with randomization to rVWF or TA study arms.
  9. Willingness to keep a personal diary of menorrhagia bleeding frequency duration and severity by pictorial blood assessment chart, and any drugs or hemostatic agents taken.
  10. Willingness to make 4 visits and undergo blood sampling for coagulation studies, and accept randomization of two therapies for each of four consecutive menstrual cycles, including an end-of-study visit.
  11. Willingness to use "double-barrier" method of contraception during the study.

Exclusion criteria

Exclusion Criteria:

  1. Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
  2. Pregnant or lactating, or use of hormones (other than progesterone-only), or combined oral contraceptives, and contraceptive implants in past 3 months.
  3. Platelet count \< 100,000/ul.
  4. Use of immunomodulatory or experimental drugs.
  5. Surgery within the past 8 weeks.
  6. Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
  7. Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing VWF within 5 days of study.
  8. Inability to comply with study requirements.
  9. Hypothyroidism as defined by elevated TSH.
  10. Iron deficiency as defined by low serum ferritin, unless iron replacement has been initiated.
  11. History of renal disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Active comparator
    Group I

    Subjects randomized to Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, tranexamic acid 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.

    Drug: recombinant von Willebrand factor · Drug: tranexamic acid

  • Active comparator
    Group II

    Group II will receive Arm B, tranexamic acid 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4.

    Drug: recombinant von Willebrand factor · Drug: tranexamic acid

Interventions

  • Drugrecombinant von Willebrand factor

    Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4. Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4.

    Also known as: vonicog alfa, Vonvendi

  • Drugtranexamic acid

    Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4. Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4.

    Also known as: Lysteda®

06

What researchers measure

Primary outcomes

  1. Menstrual Bleeding Severity

    As measured by Pictorial Blood Assessment Chart (PBAC), 0- no theoretical limit, higher score means greater severity

    Time frame: 4 weeks.

Secondary outcomes

  1. Cycle Duration

    Menorrhagia cycle length by days of bleeding (score 0 - theoretically any length)

    Time frame: 4 weeks.

  2. Ruta Menorrhagia Severity Scale

    Unit measure derived from quality of life questions reported as a single score, Minimum 0 to 100 maximum, with a higher score indicating worse outcome

    Time frame: 4 weeks.

  3. Center for Epidemiology Studies Depression Scale (CES-D)

    Reported by questions on depression, Minimum 0 to 60 Maximum, with higher scores indicating greater depression.

    Time frame: 4 weeks.

  4. Rand Short Form 36-Question Health Survey (SF-36)

    SF-36 reported by answer to questions, Minimum 0 to Maximum 100 for each of 8 domains (1-physical functioning, 2-role limitations due to physical health, 3-role limitations due to emotional problems, 4-energy and fatigue, 5-emotional wellbeing, 6-social functioning, 7-pain, and 8-general health), with higher scores for each domain meaning greater severity of physical and mental health.

    Time frame: 4 weeks

  5. Center for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14)

    Reported by answer to questions, over the past two weeks with minimum 0 to maximum 14, with higher scores indicating greater severity of physical and mental health.

    Time frame: 4 weeks.

  6. Cycle Severity

    Menorrhagia cycle severity by Likert scale, with minimum 0 to maximum 3, with higher score indicating worse severity.

    Time frame: 4 weeks

07

Results

Posted Jul 1, 2024

Participant flow

Participant flow — Overall Study
MilestoneRecombinant Von Willebrand Factor, Then Tranexamic AcidTranexamic Acid Then Recombinant Von Willebrand Factor
Started1821
Completed1719
Not completed12
Withdrew: Study closed before treament could begin12

Outcome measures

PrimaryMenstrual Bleeding Severity

As measured by Pictorial Blood Assessment Chart (PBAC), 0- no theoretical limit, higher score means greater severity

Time frame:
4 weeks.
Reported as:
Mean · score on a scale
Menstrual Bleeding Severity
score on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Menstrual Bleeding Severity225 ± 207272 ± 223
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.039 · Mean difference (final values): 46 · 95% CI 2 to 90
SecondaryCycle Duration

Menorrhagia cycle length by days of bleeding (score 0 - theoretically any length)

Time frame:
4 weeks.
Reported as:
Mean · days
Cycle Duration
daysTranexamic AcidRecombinant Von Willebrand Factor
Cycle Duration7.1 ± 4.57.0 ± 3.9
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.998 · Mean difference (final values): 0.0 · 95% CI -0.7 to 0.7
SecondaryRuta Menorrhagia Severity Scale

Unit measure derived from quality of life questions reported as a single score, Minimum 0 to 100 maximum, with a higher score indicating worse outcome

Time frame:
4 weeks.
Reported as:
Mean · units on a scale
Ruta Menorrhagia Severity Scale
units on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Ruta Menorrhagia Severity Scale32.4 ± 13.534.8 ± 13.0
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.168 · Mean difference (final values): 2.4 · 95% CI -1.0 to 5.8
SecondaryCenter for Epidemiology Studies Depression Scale (CES-D)

Reported by questions on depression, Minimum 0 to 60 Maximum, with higher scores indicating greater depression.

Time frame:
4 weeks.
Reported as:
Mean · score on a scale
Center for Epidemiology Studies Depression Scale (CES-D)
score on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Center for Epidemiology Studies Depression Scale (CES-D)13.5 ± 10.611.0 ± 10.2
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.055 · Mean difference (final values): -2.5 · 95% CI -4.9 to 0.1
SecondaryRand Short Form 36-Question Health Survey (SF-36)

SF-36 reported by answer to questions, Minimum 0 to Maximum 100 for each of 8 domains (1-physical functioning, 2-role limitations due to physical health, 3-role limitations due to emotional problems, 4-energy and fatigue, 5-emotional wellbeing, 6-social functioning, 7-pain, and 8-general health), with higher scores for each domain meaning greater severity of physical and mental health.

Time frame:
4 weeks
Reported as:
Mean · units on a scale
Rand Short Form 36-Question Health Survey (SF-36)
units on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Physical functioning84.4 ± 19.683.6 ± 20.0
Role limitations of physical health70.1 ± 39.167.4 ± 37.7
Role limitations of emotional health63.9 ± 41.768.5 ± 39.0
Energy/fatigue50.3 ± 20.647.9 ± 22.8
Emotional well-being69.2 ± 17.772.9 ± 20.0
Social functioning76.4 ± 21.980.9 ± 20.2
Pain71.2 ± 23.568.8 ± 34.2
General health58.8 ± 19.959.3 ± 21.2
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.681 · Mean difference (final values): -0.8 · 95% CI -4.8 to 3.2
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.633 · Mean difference (final values): -2.4 · 95% CI -12.4 to 7.6
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.362 · Mean difference (final values): 4.8 · 95% CI -5.7 to 15.3
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.375 · Mean difference (final values): -2.3 · 95% CI -7.4 to 2.8
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.068 · Mean difference (final values): 3.6 · 95% CI -0.3 to 7.4
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.189 · Mean difference (final values): 4.5 · 95% CI -2.3 to 11.3
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.489 · Mean difference (final values): -2.4 · 95% CI -9.2 to 4.5
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.786 · Mean difference (final values): 0.5 · 95% CI -3.2 to 4.3
SecondaryCenter for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14)

Reported by answer to questions, over the past two weeks with minimum 0 to maximum 14, with higher scores indicating greater severity of physical and mental health.

Time frame:
4 weeks.
Reported as:
Mean · units on a scale
Center for Disease Control Health-Related Quality of Life 14 Questions (CDC-HRQoL-14)
units on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Physically Unhealthy Days3.1 ± 4.01.9 ± 3.2
Mentally Unhealthy Days4.7 ± 5.15.7 ± 7.0
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.098 · Mean difference (final values): -1.0 · 95% CI -2.3 to 0.2
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.557 · Mean difference (final values): 0.7 · 95% CI -1.6 to 3.0
SecondaryCycle Severity

Menorrhagia cycle severity by Likert scale, with minimum 0 to maximum 3, with higher score indicating worse severity.

Time frame:
4 weeks
Reported as:
Mean · units on a scale
Cycle Severity
units on a scaleTranexamic AcidRecombinant Von Willebrand Factor
Cycle Severity0.96 ± 0.8791.07 ± 0.738
Statistical analysis
  • Tranexamic Acid vs Recombinant Von Willebrand Factor · Mixed Models Analysis · p = 0.266 · Mean difference (final values): 1.4 · 95% CI 0.8 to 2.7

Adverse events

Collected over Adverse Events were collected over collected a 24 week period. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tranexamic Acid0/36 (0%)0/36 (0%)4/36 (11.1%)
Recombinant Von Willebrand Factor0/36 (0%)0/36 (0%)4/36 (11.1%)
Most frequent other events
Most frequent other events
EventTranexamic AcidRecombinant Von Willebrand Factor
Other BleedingBlood and lymphatic system disorders3/362/36
Mucosal BleedingBlood and lymphatic system disorders2/360/36
HematomaBlood and lymphatic system disorders0/361/36
Injury/ Trauma BleedingBlood and lymphatic system disorders0/361/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group IGroup IITotal
<=18 years044
Between 18 and 65 years171532
>=65 years000
Age, Continuous
Age, Continuous(years)Group IGroup IITotal
Mean31.9 ± 6.326.7 ± 10.329.2 ± 8.9
Sex: Female, Male
Sex: Female, Male(Participants)Group IGroup IITotal
Female171936
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group IGroup IITotal
Hispanic or Latino257
Not Hispanic or Latino151328
Unknown or Not Reported011
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group IGroup IITotal
American Indian or Alaska Native000
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American123
White121325
More than one race000
Unknown or Not Reported246
Region of Enrollment
Region of Enrollment(participants)Group IGroup IITotal
United States171936
Menstrual Bleeding Severity
Menstrual Bleeding Severity(score on a scale)Group IGroup IITotal
Mean597 ± 389483 ± 270537 ± 331
08

Study locations

19 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • Center for Inherited Blood Disorders (CIBD)
    Orange, California 92868, United States
  • University of California San Francisco
    San Francisco, California 94117, United States
  • Emory University Afflac Blood Disorders Center
    Atlanta, Georgia 30322, United States
  • Henry Ford Hospital Medical Center
    Detroit, Michigan 48202, United States
  • Michigan State University
    East Lansing, Michigan 48824, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • Washington University St. Louis
    St Louis, Missouri 63110, United States
  • Cure4thekids Foundation
    Las Vegas, Nevada 89135, United States
  • Rutgers Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08901, United States
  • State University of New York Upstate Medical Center
    Syracuse, New York 13210, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • University of Pittsburgh and Hemophilia Center Western PA
    Pittsburgh, Pennsylvania 15213, United States
  • Vanderbilty University
    Nashville, Tennessee 37322, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
  • Bloodworks Northwest
    Seattle, Washington 98104, United States
  • Versiti Blood Center of Wisconsin
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Publications

  • Ragni MV, Machin N, Malec LM, James AH, Kessler CM, Konkle BA, Kouides PA, Neff AT, Philipp CS, Brambilla DJ. Von Willebrand factor for menorrhagia: a survey and literature review. Haemophilia. 2016 May;22(3):397-402. doi: 10.1111/hae.12898. Epub 2016 Feb 4. PubMed 26843404 ↗
  • Ragni MV, Rothenberger SD, Feldman R, Nance D, Leavitt AD, Malec L, Kulkarni R, Sidonio R Jr, Kraut E, Lasky J, Pruthi R, Angelini D, Philipp C, Hwang N, Wheeler AP, Seaman C, Machin N, Xavier F, Meyer M, Bellissimo D, Humphreys G, Smith KJ, Merricks EP, Nichols TC, Ivanco D, Vehec D, Koerbel G, Althouse AD. Recombinant von Willebrand factor and tranexamic acid for heavy menstrual bleeding in patients with mild and moderate von Willebrand disease in the USA (VWDMin): a phase 3, open-label, randomised, crossover trial. Lancet Haematol. 2023 Aug;10(8):e612-e623. doi: 10.1016/S2352-3026(23)00119-9. Epub 2023 Jun 26. PubMed 37385272 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 24, 2020
  • Informed consent form · Jan 4, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The IPD to be shared include individual bleeding data (PBAC), cycle severity score (CSR), cycle length (CL), quality of life by four scales (SF-36, Ruta, CDC-HRQoL-14, CES-D), satisfaction survey, VWF assays, VWF genotype.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Within 12 months of trial completion.

Access criteria: Qualified investigators will have access to data and bio specimens, consistent with data sharing policies and applicable laws, and upon receipt of a Research Materials Distribution Agreement, data will be transferred by secure transfers through the BioLINCC website.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02606045
Lead sponsor
Margaret Ragni
Collaborators
University of North Carolina, Duke University, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Margaret Ragni (Professor of Medicine, University of Pittsburgh) — Sponsor-investigator
First posted
Nov 17, 2015
Start date
Feb 7, 2019
Primary completion
Apr 30, 2022
Completion
Aug 30, 2022
Results posted
Jul 1, 2024
Last update
Jul 1, 2024

Study contacts

Margaret V Ragni, MD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Vonicog alfa · Tranexamic Acid

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