TA TEG: Tranexamic Acid and Thromboelastography During Cesarean Delivery

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02026297
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 67.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The aim of this study is to characterize the coagulation changes, using thromboelastography (TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically, TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo before surgery, during elective cesarean delivery, and 2 hours postpartum.

Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing interest in multimodal approaches to blood conservation during cesarean delivery. Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not been elucidated.

This study will be conducted as a randomized, double-blind, controlled trial with two study arms: control (60 patients); and treatment (60 patients).

Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT), prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured throughout surgery as per standard of care. Patients will all receive IV lactated Ringers' (LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general anesthesia conversion, general anesthesia planned), indications and medication doses used will be noted for analysis.

Immediately following induction of anesthesia and prior to skin incision, infusion of study solution will be initiated.

Study solutions will consist of:

1. Control group: 100 mL 0.9% normal saline (NS).

2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured throughout the study. All routine care lab values will be noted. At minimum, one lab panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen, platelet count, aPTT, PT, and TEG).

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Tranexamic Acid; Drug: Placebo; Normal Saline	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Influence of Prophylactic Tranexamic Acid on Thromboelastography During Cesarean Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Feb 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control, low risk PPH Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid.	Drug: Placebo; Normal Saline; 0.9% Normal Saline
Experimental: Treated, low risk PPH Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid.	Drug: Tranexamic Acid; 1 gram IV over 10 minutes

Outcome Measures

Primary Outcome Measures

1. TEG Value- Thromboelastography R-time, Control and Treated Groups [one hour after initiation of study infusion]

   Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.

2. Intraoperative Blood Loss [during surgery in the operating room]

   Blood loss will be measured using the following methods: visual estimate of blood in the suction canister weight of surgical sponges postoperative hemoglobin values

3. Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician. [6 weeks postpartum]

   The electronic patient record from each patients' 6-week postpartum visit will be reviewed for the following: delayed bleeding complications, defined as obstetric bleeding requiring surgical intervention, blood transfusion, or both. thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) class I or II

• aged 18-50 years

• singleton vertex pregnancy

• scheduled elective cesarean delivery (with or without prior labor) with a planned pfannenstiel incision

Exclusion Criteria:

• allergy to tranexamic acid

• history of inherited or acquired thrombophilia

• history of deep vein thrombosis or pulmonary embolism, or use of anticoagulant medication.

• preeclampsia, hemolysis, elevated liver enzymes, low platelet syndrome

• seizure disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michaela Kristina Farber, MD, Instructor of Anesthesia, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02026297
• Other Study ID Numbers: 2013P002452
• First Posted: Jan 1, 2014
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Michaela Kristina Farber, MD, Instructor of Anesthesia, Brigham and Women's Hospital: postpartum hemorrhage; estimated blood loss; coagulation; thromboelastography; tranexamic acid
• Additional relevant MeSH terms: Postpartum Hemorrhage; Hemorrhage; Tranexamic Acid

Study Results

Participant Flow

Arm/Group Title	Control, Low Risk PPH	Treated, Low Risk PPH
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes
Period Title: Overall Study
STARTED	7	13
COMPLETED	7	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control, Low Risk PPH	Treated, Low Risk PPH	Total
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes	Total of all reporting groups
Overall Participants	7	13	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	13 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35.2	31.9	32.9
Sex: Female, Male (Count of Participants)
Female	7 100%	13 100%	20 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	13 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	TEG Value- Thromboelastography R-time, Control and Treated Groups
Description	Blood samples will be collected for evaluation one our after initiation of the study infusion. Whole blood samples are tested in a point-of-care thromboelastography machine and R time, or time to initiation of clot formation, is measured in minutes.
Time Frame	one hour after initiation of study infusion

Outcome Measure Data

Analysis Population Description

Thromboelastography R-time

Arm/Group Title	Control, Low Risk PPH	Treated, Low Risk PPH
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes
Measure Participants	7	13
Mean (Inter-Quartile Range) [minutes]	5.3	4.2

2. Primary Outcome

Title	Intraoperative Blood Loss
Description	Blood loss will be measured using the following methods: visual estimate of blood in the suction canister weight of surgical sponges postoperative hemoglobin values
Time Frame	during surgery in the operating room

Outcome Measure Data

Analysis Population Description

weight of surgical sponges

Arm/Group Title	Control, Low Risk PPH	Treated, Low Risk PPH
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes
Measure Participants	7	13
Mean (Standard Error) [milliliters]	637 (151)	685 (155)

3. Primary Outcome

Title	Delayed Complications at the 6-Week Postpartum Visit With the Obstetrician.
Description	The electronic patient record from each patients' 6-week postpartum visit will be reviewed for the following: delayed bleeding complications, defined as obstetric bleeding requiring surgical intervention, blood transfusion, or both. thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
Time Frame	6 weeks postpartum

Outcome Measure Data

Analysis Population Description

postpartum Obstetrician evaluation at 6 weeks: obstetric bleeding requiring surgical intervention, blood transfusion, or both; thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event

Arm/Group Title	Control, Low Risk PPH	Treated, Low Risk PPH
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes
Measure Participants	7	13
Number [complications]	0	0

Adverse Events

Time Frame	All patients enrolled in this study were evaluated in the immediate treatment period through the time of discharge (average duration 4 days) and then records were reviewed from the 6-week postpartum followup for delayed complications.
Adverse Event Reporting Description	obstetric bleeding requiring surgical intervention, blood transfusion, or both. thrombotic complications including: venous thrombus seen on ultrasound, thromboembolic event
Arm/Group Title	Control, Low Risk PPH		Treated, Low Risk PPH
Arm/Group Description	Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care NOT including tranexamic acid. Placebo; Normal Saline: 0.9% Normal Saline		Patients at lower risk for postpartum hemorrhage during cesarean delivery, to receive standard of care AND tranexamic acid. Tranexamic Acid: 1 gram IV over 10 minutes
All Cause Mortality
	Control, Low Risk PPH		Treated, Low Risk PPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Serious Adverse Events
	Control, Low Risk PPH		Treated, Low Risk PPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Control, Low Risk PPH		Treated, Low Risk PPH
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.