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Antifibrinolytic
TXA (1g) for Postpartum Hemorrhage (TAPPH-1 Trial)
Phase 2
Waitlist Available
Led By Asim Q Alam, MD, FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Summary
This trial is being done to see if the prophylactic use of TXA can safely reduce the rate of PPH and the need for blood transfusions in women having a cesarean section.
Eligible Conditions
- Postpartum Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients receiving study intervention
Secondary outcome measures
Composite number of clinical events
Duration of study to recruit 58 participants
Incidence of PPH in study participants
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TXA (1g)Experimental Treatment1 Intervention
For vaginal, TXA (1g) will be administered upon delivery of the anterior shoulder. For c-section, TXA (1g) will be administered when the obstetrician begins to cleanse the incision site
Group II: Placebo (0.9% saline)Placebo Group1 Intervention
For vaginal, placebo (0.9% saline) will be administered upon delivery of the anterior shoulder. For c-section, placebo (0.9% saline) will be administered when the obstetrician begins to cleanse the incision site
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
671 Previous Clinical Trials
1,564,604 Total Patients Enrolled
Asim Q Alam, MD, FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre
Stephen Choi, MD,FRCPC,MScPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
777 Total Patients Enrolled
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