Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481995
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-31
Brief Title:
SWIFT - SWIss Factor XIII Trial in PPH
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Early Factor XIII Replacement in Postpartum Hemorrhage Multi-center Randomized Controlled Investigator-initiated Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SWIFT
Brief Summary:
The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII FXIII at an early stage of postpartum hemorrhage PPH
Summary of current body of evidence
Morbidity and mortality due to PPH is rising
Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy despite non-conclusive evidence in all prospective trials
Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss
Therefore this nationwide multi-center randomized controlled trial in multiple perinatal centers across Switzerland will be conducted The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII
All participating women receive according to the national guideline 1g tranexamic acid TXA iv in case of PPH measured blood loss MBL 500 mL during the pre-study phase Randomization takes place if bleeding continues and exceeds 700mL The intervention group then receives FXIII Fibrogammin according to approved dosage in addition to obstetric standard of care treatment for causes of PPH the control group receives only standard of care treatment
Summary of current body of evidence
Morbidity and mortality due to PPH is rising
Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy despite non-conclusive evidence in all prospective trials
Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss
Therefore this nationwide multi-center randomized controlled trial in multiple perinatal centers across Switzerland will be conducted The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII
All participating women receive according to the national guideline 1g tranexamic acid TXA iv in case of PPH measured blood loss MBL 500 mL during the pre-study phase Randomization takes place if bleeding continues and exceeds 700mL The intervention group then receives FXIII Fibrogammin according to approved dosage in addition to obstetric standard of care treatment for causes of PPH the control group receives only standard of care treatment
Detailed Description:
Postpartum hemorrhage PPH is a main reason for maternal mortality and morbidity PPH defined by the WHO as blood loss of 500 mL or more within 24 hours after delivery causes about 30 of maternal deaths worldwide The internationally observed trend towards increased PPH-related morbidity and mortality is disturbing and demands new strategies in the prevention and treatment of PPH
Although the most frequent causes for severe PPH are believed to be uterine atony or retained placenta virtually all cases of severe PPH lead to a disorder of the coagulation system which itself aggravates bleeding
At the moment most guidelines on coagulation management during PPH and expert opinions focus on the replenishment of coagulation factor I fibrinogen although three out of three randomized controlled trials with early or pre-emptive administration of fibrinogen during PPH were negative
Based on earlier research it was hypothesized that coagulation factor XIII FXIII might play a significant role in women with increased postpartum blood loss because of its role in the establishment of blood clot stability and fibrinolytic resistance This hypothesis was tested in a prospective diagnostic study involving 1300 parturient women at the University Hospital Zurich and showed that pre-partum factor XIII activity had a strong association to postpartum blood loss
Therefore this nationwide multi-center open-label randomized controlled trial in major perinatal centers across Switzerland will be conducted The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by substitution of FXIII at an early stage of PPH
Irrespective of the answer to the question whether FXIII is effective in the treatment of PPH this trial will contribute to enhancing the comprehension of coagulopathy in the context of PPH
Although the most frequent causes for severe PPH are believed to be uterine atony or retained placenta virtually all cases of severe PPH lead to a disorder of the coagulation system which itself aggravates bleeding
At the moment most guidelines on coagulation management during PPH and expert opinions focus on the replenishment of coagulation factor I fibrinogen although three out of three randomized controlled trials with early or pre-emptive administration of fibrinogen during PPH were negative
Based on earlier research it was hypothesized that coagulation factor XIII FXIII might play a significant role in women with increased postpartum blood loss because of its role in the establishment of blood clot stability and fibrinolytic resistance This hypothesis was tested in a prospective diagnostic study involving 1300 parturient women at the University Hospital Zurich and showed that pre-partum factor XIII activity had a strong association to postpartum blood loss
Therefore this nationwide multi-center open-label randomized controlled trial in major perinatal centers across Switzerland will be conducted The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by substitution of FXIII at an early stage of PPH
Irrespective of the answer to the question whether FXIII is effective in the treatment of PPH this trial will contribute to enhancing the comprehension of coagulopathy in the context of PPH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None