Trial Outcomes & Findings for Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE) (NCT NCT04635839)

NCT ID: NCT04635839

Last Updated: 2023-04-28

Results Overview

Surrogate marker for whether or not the patient would be eligible for neuraxial anesthesia based on guidelines for neuraxial anesthesia in pregnant women receiving VTE prophylaxis

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
• Results posted on: 2023-04-28

Participant Flow

Participant milestones

Measure	Standard Dosing Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Overall Study STARTED	22	24
Overall Study COMPLETED	21	24
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Standard Dosing Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Overall Study Delivered prior to second dose of heparin	1	0

Baseline Characteristics

Heparin Prophylaxis Dosing for Antepartum Hospitalizations (HEPDOSE)

Baseline characteristics by cohort

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours	Total n=45 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	34 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	24 participants n=7 Participants	45 participants n=5 Participants
Gravida	2 pregnancies n=5 Participants	2 pregnancies n=7 Participants	2 pregnancies n=5 Participants
Nulliparous	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Gestational age at randomization	30.3 weeks n=5 Participants	30.4 weeks n=7 Participants	30.3 weeks n=5 Participants
Body mass index	29.9 kg/m^2 n=5 Participants	30.4 kg/m^2 n=7 Participants	30.1 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Surrogate marker for whether or not the patient would be eligible for neuraxial anesthesia based on guidelines for neuraxial anesthesia in pregnant women receiving VTE prophylaxis

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).	1 Participants	8 Participants

SECONDARY outcome

Timeframe: Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed at time of delivery

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed at time of delivery

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants That Received General Anesthesia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed at time of delivery

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Maximum Anti-Factor Xa Level Measured	0.09 IU/mL Interval 0.09 to 0.09	0.09 IU/mL Interval 0.09 to 0.11

SECONDARY outcome

Timeframe: Assessed at time of delivery

Population: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and mode of delivery is unavailable

Outcome measures

Measure	Standard Dosing n=20 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Mode of Delivery Vaginal delivery	6 Participants	4 Participants
Mode of Delivery Cesarean delivery	14 Participants	20 Participants

SECONDARY outcome

Timeframe: Assessed at time of delivery

Population: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and estimated blood loss is unavailable

Outcome measures

Measure	Standard Dosing n=20 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Estimated Blood Loss From Delivery	654 cc Interval 125.0 to 1344.0	593 cc Interval 505.0 to 905.0

SECONDARY outcome

Timeframe: From time of delivery until 6 weeks after delivery

Population: 1 participant in Arm 1 (standard dosing) delivered at an outside hospital and need for blood transfusion is unavailable

Outcome measures

Measure	Standard Dosing n=20 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Number of Participants That Received a Blood Transfusion	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week

Outcome measures

Measure	Standard Dosing n=21 Participants Standard dose of unfractionated heparin Standard Dose of Unfractionated Heparin: 5,000 units subcutaneous unfractionated heparin every 12 hours	Gestational Age-Based Dosing n=24 Participants Dose of unfractionated heparin based on trimester of pregnancy Gestational Age-Based Dose of Unfractionated Heparin: - First trimester (\< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours * Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours * Third trimester (\> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours
Maximum Activated Partial Thromboplastin Clotting Time Levels Measured	26.6 seconds Interval 23.0 to 29.6	30.4 seconds Interval 7.4 to 37.5

Adverse Events

Standard Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gestational Age-Based Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thalia Mok

University of California, Los Angeles

Phone: 310-794-7274

Email: tmok@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place