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Bapak/ Ibu Yth,
Saya dr. Edisyah Raskita saat ini sedang menjalani Program Pendidikan Dokter
Spesialis Patologi Klinik di RSUP H. Adam Malik Medan dan saya sedang
melakukan penelitian yang berjudul : “PENGARUH DABIGATRAN TERHADAP
PROTROMBIN TIME, ACTIVATED PARTIAL THROMBIN TIME, THROMBIN
TIME dan TROMBOSIT PADA PASIEN PASKA STROKE ISKEMIK
KARDIOEMBOLI”. Penelitian ini mengenai pengaruh obat dabigatran yang dapat
mencegah terjadinya stroke ulangan pada penderita yang telah mengalami
stroke. Untuk membuktikan hal tersebut maka saya akan mengikutsertakan
Bapak dan Ibu dalam penelitian ini dengan tujuan untuk mengetahui apakah obat
ini benar dapat mencegah terjadinya stroke ulangan pada Bapak dan Ibu yang
menderita stroke tanpa perdarahan.
Untuk itu saya mencatat identitas Bapak/ Ibu, tanggal berobat, No Rekam Medik,
Nama, Umur, Jenis Kelamin, Tekanan Darah, Berat Badan, Pekerjaan, Alamat.
Selanjutnya saya akan mengambil darah Bapak/ Ibu sebanyak 5 cc pada lengan
Bapak/ Ibu. Dalam penelitian ini Bapak/ Ibu tidak dikenakan biaya apa-apa.
Manfaat dari penelitian ini adalah dengan mengetahui efek obat dabigatran ini
pada Bapak/ Ibu yang menderita stroke tanpa perdarahan diharapkan dapat
menencegah terjadinya stroke ulangan yang memang sering terjadi pada
penderita stroke seperti penyakit yang sedang Bapak/ Ibu alami.
Bapak/ Ibu Yth
Obat yang saya berikan ini sudah beredar dan sudah dipakai untuk tujuan seperti
(HP : 082165634344 atau 085664004344) atau menjumpai saya di Departemen
Patologi Klinik RSUP H. Adam Malik Medan setiap hari kerja. Saya akan
bertanggung jawab untuk memberikan pertolongan/ biaya/ pengobatan/
membantu mengatasi masalah/ efek samping tersebut.
Bapak/ Ibu Yth
Partisipasi Bapak/ Ibu bersifat suka rela, semua biaya penelitian ini tidak
dibebankan kepada Bapak/ Ibu. Tidak akan terjadi perubahan mutu pelayanan
dari dokter, apabila Bapak/ Ibu tidak bersedia ikut dalam penelitian ini. Bila masih
belum jelas maka Bapak/ Ibu dapat menanyakan langsung pada saya. Pada
penelitian ini identias Bapak/ Ibu akan disamarkan. Hanya dokter peneliti,
anggota peneliti dan anggota komisi etik yang bias melihat data Bapak/ Ibu.
Kerahasiaan data Bapak Ibu sepenuhnya akan dijamin. Setelah Bapak/ Ibu
memahami berbagai hal yang menyangkut penelitian ini, diharapkan Bapak/ Ibu
yang telah terpilih pada penelitian ini dapat mengisi dan menandatangani lembar
persetujuan penelitian.
Medan,……… 2014
Peneliti
