Warfarin Initiation in Mechanical Mitral Valve Replacement Patients
Ključne besede
Povzetek
Opis
Inpatients of The Cardiovascular hospital who had undergone mitral heart valve replacement with a mechanical prosthesis and commencing warfarin were eligible for inclusion. Patients were included after they had newly undergone elective surgery for implantation of mechanical mitral heart valves, had commenced on warfarin, received enoxaparin as a bridging agent and had INR monitored for a minimum of 4 consecutive days after warfarin initiation.
A total of 50 consecutive MVR patients were recruited. Each was assigned to either the group I (25 patients) or the group II (25 patients) group. All patients received the conventional postoperative treatment including: Diuretics, beta-blockers, digoxin or heart rate-regulating calcium channel blockers and anticoagulation bridging therapy using LMWH according to the European Society of Cardiology (ESC) Guidelines for the management of MVR and antibiotic for 48hour after surgery according to the investigator's hospital's antibiotic protocol.
Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. were documented for each patient. Medication history in details, as well as the background cardiovascular treatment was considered.
Blood samples were withdrawn from patients for evaluation of INR. Complete blood count, kidney and liver function tests were performed as part of the routine admission care.
All patients were followed up daily post operative till reaching an in range INR value. All patients were observed daily for INR values and dose adjusted accordingly and also estimation of incidence and severity of bleeding complications was done.
Datumi
| Nazadnje preverjeno: | 12/31/2019 |
| Prvič predloženo: | 01/14/2020 |
| Predviden vpis oddan: | 01/15/2020 |
| Prvič objavljeno: | 01/21/2020 |
| Zadnja posodobitev oddana: | 01/22/2020 |
| Zadnja posodobitev objavljena: | 01/26/2020 |
| Dejanski datum začetka študija: | 02/28/2018 |
| Predvideni datum primarnega zaključka: | 12/31/2018 |
| Predvideni datum zaključka študije: | 08/31/2019 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Group I
Drug: Group II
Drug: Enoxaparin Sodium 100 MG/ML Prefilled Syringe
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Group I a group of 25 patients received 5mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range.
Bleeding events due to overanticoagulation were monitored through the follow up period. | Drug: Group I warfarin sodium 5mg tablets |
| Experimental: Group II a group of 25 patients received 3mg Marevan ® tablets as initiation warfarin dose in combination of enoxaparin (Clexane® ) as a bridging agent.INR was monitored daily and dose adjustments were done to reach therapeutic INR range (2-3) at which the Enoxaparen was discontinued.Follow up was continued till first INR reading in therapeutic range.
Bleeding events due to overanticoagulation were monitored through the follow up period. | Drug: Group II warfarin sodium 3mg tablets |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | Inclusion Criteria: - New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent. Exclusion Criteria: - Pregnant or lactating women - Renal disorder (GFR = 45< mL/min) or patients on renal dialysis - Hepatic disorder (Child Pugh class B or C) - Clinically significant active bleeding. - Recurrent DVT or PE. - Baseline INR >1.2 - Asian ancestry - Cancer - Impaired nutritional status - Alcohol abuse |
Izid
Primarni izidni ukrepi
1. Efficacy of warfarin initiating dose and the corresponding dosing schedule: Time to reach therapeutic INR range (TTR) [4-16 days]
Ukrepi sekundarnega rezultata
1. Evaluation of overanticoagulation [from 3 to 5 days]
2. Anticoagulation Safety evaluation [from 4 to 16 days]
3. Low Molecular Weight Heparin consumption [from 4 to 16 days]
4. The Overall cost evaluation [from 4 to 16 days]
