NCT03125551

ROTEM and Dietary Supplements

Viscoelastic Point-of-Care Coagulation Monitoring and Dietary Supplements: A Randomized, Double-blind, Placebo-controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pretoria · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Dietary Supplements can affect platelet activation and aggregation, which could result in bleeding tendencies. This study wishes to evaluate the influence that these supplements has on platelet function using Rotational thromboelastometry.

Detailed description

The WHO informs us that more than 80% of patients in Africa use traditional/herbal medicines as their primary source of health care. The Mayo Clinic stated that nearly 40% of adults reported using complementary and alternative medicine (CAM). Many of these herbal medicines as well as dietary supplements have effects on the coagulation cascade and have been identified as such using laboratory tests including aPTT, PT, INR, light transmission aggregometry and impedence aggregometry to mention but a few. This study wishes to evaluate coagulation abnormalities using viscoelastic point-of-care coagulation monitoring in this population. This test is readily available in large hospitals and academic settings and is increasingly being used in perioperative medicine. It provides information on coagulation and thrombolysis with minimal delay when compared to other laboratory-based coagulation tests. The dietary supplements which will be evaluated in this study are ginger, garlic, gingko biloba and ginseng. These four herbal supplements were identified as the most commonly used substances known to modulate the coagulation system. These herbal supplements will be investigated within their maximum daily allowance dosages. A five-armed placebo-controlled study will be undertaken and study subjects will be recruited on a volunteer basis. Subjects will be divided into five groups and each group will receive one of the four dietary supplements and the fifth group placebo, for a two week period. Rotational thromboelastometry (ROTEM) studies will be performed on blood samples obtained from each participant at baseline and at the end of the treatment period to identify coagulation abnormalities. Most of these herbal medicines have been identified to affect platelet function and this study will specifically look at platelet function determined by maximum clot firmness (MCF) in the ROTEM analysis. Viscoelastic point-of-care coagulation monitoring in patients using herbal medicines and dietary supplements will aid decision making regarding cause of perioperative haemorrhage and need for specific blood products. It will therefore assist with goal-directed management of perioperative haemorrhage. It will also aid the anaesthetist wishing to employ a regional anaesthetic technique in this patient group.

Conditions

• Dietary Supplements
• Bleeding Tendency; Due to Coagulation Defect

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ginger	Ginger dosage at daily recommended allowance
DIETARY_SUPPLEMENT	Garlic	Garlic dosage at daily recommended allowance
DIETARY_SUPPLEMENT	Ginkgo Biloba	Ginkgo Biloba dosage at daily recommended allowance
DIETARY_SUPPLEMENT	Ginseng	Ginseng dosage at daily recommended allowance
OTHER	Placebo	Daily dosage strategy

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2017-04-24
• Last updated: 2018-05-09