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IV Ketorolac on Platelet Function Post-Cesarean Delivery (KetoPltAgg)

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ClinicalTrials.gov Identifier: NCT03805607
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Society for Obstetric Anesthesia and Perinatology
Information provided by (Responsible Party):
John J. Kowalczyk, Beth Israel Deaconess Medical Center

Brief Summary:
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence and degree of platelet inhibition after NSAID exposure is less clear. The investigators plan to use Platelet Aggregometry and Thromboelastography (TEG) to evaluate the effect of ketorolac on platelets.

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Postoperative Pain Coagulation Defect; Postpartum Nonsteroidals (NSAIDs)Toxicity Postpartum Hemorrhage Drug: Ketorolac Tromethamine 30 MG/ML Drug: Placebos Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Double-blind Placebo Controlled Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Placebo (normal saline) or ketorolac in syringe prepared by the investigational pharmacy with study patient number and blinding key maintained by investigational pharmacy until time of unblinding.
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of the Effects of IV Ketorolac on Platelet Function Post-Cesarean Delivery
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: Placebo
1 ml of normal saline
Drug: Placebos
Normal Saline
Other Names:
  • Placebo
  • Normal Saline

Experimental: Ketorolac
30 mg of ketorolac in 1 ml
Drug: Ketorolac Tromethamine 30 MG/ML
Ketorolac 30 mg
Other Names:
  • ketorolac
  • Ketorolac Tromethamine
  • Ketorolac Injectable Solution




Primary Outcome Measures :
  1. Platelet Aggregometry Percent Light Transmission [ Time Frame: 15 minutes after dosing of placebo or ketorolac ]
    Platelet Aggregometry uses measurements platelet rich blood or serum samples and activating agents to analyze the percent change in light transmission as a marker of platelet aggregation.


Secondary Outcome Measures :
  1. Thromboelastogram parameters including Reaction time (R) [ Time Frame: 15 minutes after dosing of placebo or ketorolac ]
    Thromboelastogram parameters including Reaction time (R)

  2. Thromboelastogram parameters including Angle (alpha) [ Time Frame: 15 minutes after dosing of placebo or ketorolac ]
    Thromboelastogram parameters including Angle (alpha)

  3. Thromboelastogram parameters including Kinetics (K) [ Time Frame: 15 minutes after dosing of placebo or ketorolac ]
    Thromboelastogram parameters including Kinetics (K)

  4. Thromboelastogram parameters including Maximum Amplitude (MA) [ Time Frame: 15 minutes after dosing of placebo or ketorolac ]
    Thromboelastogram parameters including Maximum Amplitude (MA)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Undergoing routine, scheduled cesarean section
  • Gestation >37 weeks
  • Singleton gestation
  • Intraoperative anesthesia - 1.5 ml of intrathecal bupivicaine 0.75%, 25mcg of intrathecal fentanyl and 250 mcg of intrathecal morphine via Spinal or Combined Spinal Epidural

Exclusion Criteria:

  • Pre-eclampsia with severe features or HELLP
  • Allergy to NSAIDs
  • Pre-existing bleeding disorder
  • Other major risk factor for postpartum hemorrhage (placenta accreta, large uterine fibroid)
  • Chronic kidney disease
  • Plt count less than 100k
  • Gastric ulcer or gastric bleeding
  • Pre-existing uterine bleeding or disseminated intravascular coagulation
  • Patient or Obstetrician refusal
  • Intraoperative exclusion criteria - Postpartum hemorrhage (EBL >1000 ml) or unplanned intraoperative extension of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805607


Contacts
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Contact: John J Kowalczyk, MD 617-667-3112 jkowalcz@bidmc.harvard.edu
Contact: Phil Hess, MD 617-667-3112 phess@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Society for Obstetric Anesthesia and Perinatology

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Responsible Party: John J. Kowalczyk, Instructor in Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03805607     History of Changes
Other Study ID Numbers: 2018P000625
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by John J. Kowalczyk, Beth Israel Deaconess Medical Center:
Cesarean Section Complications
Postoperative Pain
Coagulation Defect; Postpartum
Nonsteroidals (NSAIDs)Toxicity
Postpartum Hemorrhage
Ketorolac
Cesarean Delivery
Platelet Function

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Hemorrhage
Pain, Postoperative
Postpartum Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors