Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480545
Status:
WITHDRAWN
Last Update Posted:
2014-12-05
First Post:
2007-05-29
Brief Title:
Changes in Bleeding and Clotting During the Menstrual Cycle
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB Approval lapsed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Indirect evidence suggests that hormonal fluctuations during the menstrual cycle also affect the bleeding and clotting system This study looks at two sensitive laboratory tests at four time points during the menstrual cycle to determine if there is a natural variation in coagulation and platelet function Laboratory tests in healthy subjects will be compared to women with von Willebrands disorder type 1 a bleeding disorder In the future these laboratory tests may help in the diagnosis of bleeding and clotting disorders and to design treatments for women with abnormal menstrual bleeding
Detailed Description:
Von Willebrand disease VWD is the most common hereditary bleeding disorder occurring in 1-2 of the population Menorrhagia or heavy menstrual bleeding occurs in the majority of women with von Willebrand disease VWD and adversely affects quality of life The American College of Obstetrics and Gynecology has recommended that women with heavy menstrual bleeding have diagnostic testing for VWD Unfortunately the diagnosis of VWD in women with menorrhagia can be difficult due to fluctuations in hemostatic protein levels during the menstrual cycle The lack of useful coagulation assays has also limited the scope of pharmacokinetic studies and comparative clinical trials needed to determine best clinical practices in women with VWD
Two new assay systems offer a possibility of increased sensitivity to physiologic variations in coagulation and fibrinolysis The calibrated automated thrombin generation assay TG an estimation of endogenous thrombin potential ETP measures generation of thrombin throughout the entire process of coagulation and has appears to be very sensitive to small changes in levels of coagulation proteins Thromboelastography TEG records clot formation and dissolution in whole blood samples providing a good marker for fibrinolysis We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variations in hemostasis during the menstrual cycle and can accurately diagnose VWD This is a single-institution pilot study to identify trends which are worthy of further exploration in a larger multi-institutional study Our primary objective is to describe characteristics of TG and TEG at 4 time points during the menstrual cycle days 0-3 7-10 14-17 and 21-24 Our secondary goal is to quantify the effects of VWD on TG and TEG at the same time points during the menstrual cycle and compare these to traditional coagulation assays
This will be a single-institution pilot study of a total of 40 subjects 20 healthy women and 20 women with VWD Subjects must be female between the ages of 18 and 50 years have regular menstrual periods and not be pregnant Women who are taking hormonal therapy anti-fibrinolytic therapy hemostatic agents or anti-platelet agents will not be eligible for participation Subjects will be given tampons andor pads to use during one menstrual cycle Study participation will involve a brief interview completion of a questionnaire and a pictorial chart of one menstrual cycle and having blood drawn at 4 time points during one menstrual cycle Blood samples will be collected for TG and TEG and standard assays of coagulation and fibrinolysis TG and TEG measurements will be compared to standard measures of coagulation fibrinolysis and platelet activation markers Serum from the visit on day 21-24 will be tested for progesterone and Bhcg to confirm ovulation and exclude pregnancy All assays will be performed at the Gulf States Hemophilia Thrombophilia coagulation laboratory
This study will result in an improved capability to diagnose women with VWD during the menstrual cycle These new assays may be useful in the rational design of therapeutic agents and clinical trials In addition the physiologic basis of variations in coagulation during the menstrual cycle can be explored in future studies using this assay system
Two new assay systems offer a possibility of increased sensitivity to physiologic variations in coagulation and fibrinolysis The calibrated automated thrombin generation assay TG an estimation of endogenous thrombin potential ETP measures generation of thrombin throughout the entire process of coagulation and has appears to be very sensitive to small changes in levels of coagulation proteins Thromboelastography TEG records clot formation and dissolution in whole blood samples providing a good marker for fibrinolysis We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variations in hemostasis during the menstrual cycle and can accurately diagnose VWD This is a single-institution pilot study to identify trends which are worthy of further exploration in a larger multi-institutional study Our primary objective is to describe characteristics of TG and TEG at 4 time points during the menstrual cycle days 0-3 7-10 14-17 and 21-24 Our secondary goal is to quantify the effects of VWD on TG and TEG at the same time points during the menstrual cycle and compare these to traditional coagulation assays
This will be a single-institution pilot study of a total of 40 subjects 20 healthy women and 20 women with VWD Subjects must be female between the ages of 18 and 50 years have regular menstrual periods and not be pregnant Women who are taking hormonal therapy anti-fibrinolytic therapy hemostatic agents or anti-platelet agents will not be eligible for participation Subjects will be given tampons andor pads to use during one menstrual cycle Study participation will involve a brief interview completion of a questionnaire and a pictorial chart of one menstrual cycle and having blood drawn at 4 time points during one menstrual cycle Blood samples will be collected for TG and TEG and standard assays of coagulation and fibrinolysis TG and TEG measurements will be compared to standard measures of coagulation fibrinolysis and platelet activation markers Serum from the visit on day 21-24 will be tested for progesterone and Bhcg to confirm ovulation and exclude pregnancy All assays will be performed at the Gulf States Hemophilia Thrombophilia coagulation laboratory
This study will result in an improved capability to diagnose women with VWD during the menstrual cycle These new assays may be useful in the rational design of therapeutic agents and clinical trials In addition the physiologic basis of variations in coagulation during the menstrual cycle can be explored in future studies using this assay system
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